Backaid Caffeine

Backaid Caffeine
SPL v2
SPL
SPL Set ID 25db6bb5-96b6-4be1-e063-6294a90a2300
Route
ORAL
Published
Effective Date 2024-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (75 mg) Acetaminophen (500 mg)
Inactive Ingredients
Maltodextrin Starch, Corn Croscarmellose Sodium Hypromelloses Talc Cellulose, Microcrystalline Polydextrose Silicon Dioxide C10-18 Triglycerides Stearic Acid Titanium Dioxide Povidone

Identifiers & Packaging

Pill Appearance
Imprint: ALVA Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

Acetaminophen, 500 mg Caffeine, 75 mg

Purpose

Analgesic (pain reliever) Analgesic aid


Medication Information

Purpose

Analgesic (pain reliever)

Analgesic aid

Description

Acetaminophen, 500 mg Caffeine, 75 mg

Uses

For the temporary relief of minor aches and pains associated with

  • backache
  • muscular aches
  • headache
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50567-7

When using this product, limit the use of caffeine-containing medications, foods or beverages because too mush caffeine may cause

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heartbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have liver disease.

Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • Read all package directions and warnings before use. Use only as directed.
  • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
  • Do not exceed recommended dosage.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.
Questions?

1-800-792-2582.

Package Insert

New & Improved Formula

Maximum Strength

BACKAID

6 Hour Formula

Acetaminophen + Caffeine

  • Eases Pain of Inflammation
  • Relieves Backache and Sciatica Pain

Active ingredients: Each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and caffeine anhydrous 75 mg (analgesic aid).

Uses: For the temporary relief of minor aches and pains associated with • backache • muscular aches • headache

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets in 24 hours, which is the maximum dally amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much cafeine may cause

  • nervousness
  • irritability
  • sleeplessness
  • occassional rapid heatbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or welling is present
  • any new symptoms appear

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

  • Read all package directions and warnings before use. Use only as directed.
  • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
  • Do not exceed recommended dosage.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.

Other information:

**CONTENTS SEALED: Each BACKAID white colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing or in a bottle with a safety seal under the cap. Do not use if seal appears broken or if product contents do not match product description. • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Questions? 1-800-792-2582

Fórmula nueva y mejorada

Maxima concentración

BACKAID

Fórmula de 6 horas

Acetaminofeno + cafeina

  • Alivia el dolor de la inflamación
  • Alivia el dolor de espalda y el dolor ciático

Ingredientes activos: Cada comprimido oblongo contiene: 500 mg de acetaminofeno (un analgésico, alivia el dolor) y 75 mg de cafeína anhidra (ayuda analgésica).

Usos: Para el alivio temporal de dolores menores asociados con

  • dolor de espalda
  • dolores musculares
  • dolor de cabeza

Advertencias:

Advertencia hepática: Este producto contiene acetaminofeno. Puede producirse un daño hepático grave si usted toma:

  • más de 6 comprimidos oblongos en 24 horas, que es la cantidad diaria máxima
  • otros fármacos que contienen acetaminofeno al mismo tiempo
  • 3 o más bebidas alcohólicas cada día mientras usa este producto.

Alerta de alergias: El acetaminofeno puede causar reacciones graves en la piel. Los síntomas pueden incluir:

  • enrojecimiento de la piel
  • ampollas
  • sarpullido

Si se produce una reacción en la piel, deje de usar el producto y busque ayuda médica de inmediato.

No lo use

  • con ningún otro fármaco que contenga acetaminofeno (de venta con receta o sin ella). Si no está seguro respecto de si un fármaco contiene acetaminofeno o no, pregúntele a un médico o farmacéutico.

Pregúntele a un médico antes de usarlo si tiene enfermedad hepática.

Pregúntele a un médico o farmacéutico antes de usarlo si está tomando el fármaco anticoagulante warfarina.

Cuando use este producto, limite el uso de medicamentos, alimentos o bebidas que contengan cafeína ya que demasiada cafeína puede provocar:

  • nerviosismo
  • irritabilidad
  • insomnio
  • latidos cardíacos rápidos ocasionales

La dosis recomendada de este producto contiene aproximadamente la misma cantidad de cafeína que una taza y media de café.

Deje de usarlo y consulte a un médico si

  • el dolor empeora o dura más de 10 días
  • la fiebre empeora o dura más de 3 días
  • aparece enrojecimiento o hinchazón
  • se presentan síntomas nuevos.

Si está embarazada o está amamantando, consulte a un profesional de la salud antes de usarlo.

Manténgalo fuera del alcance de los niños. En caso de sobredosis, obtenga ayuda médica o comuníquese de inmediato con un centro de toxicología. La atención médica inmediata es fundamental tanto para los adultos como para los niños, incluso si no observa signos ni síntomas.

Indicaciones:

  • Lea todas las indicaciones y advertencias del envase antes de usarlo. Usar según indicaciones.
  • Adultos: Dos (2) comprimidos oblongos con un vaso lleno de agua cada 6 horas mientras los síntomas persisten, sin exceder las 3 dosis (6 comprimidos oblongos) en 24 horas, o según lo indique un médico.
  • No exceda la dosificación recomendada.
  • Para uso por parte de adultos normalmente sanos únicamente.
  • Las personas menores de 18 años deben usarlo solo según las indicaciones de un médico.

Información adicional:

  • **CONTENIDO SELLADO: Cada comprimido de BACKAID, de forma ovalada y color blanco, lleva la marca identificatoria “ALVA” y está sellado en un blíster de plástico transparente con un recubrimiento posterior de papel/aluminio, o en un frasco con un sello de seguridad debajo de la tapa. No lo use si el sello parece estar roto o si el contenido del producto no coincide con la descripción del producto.
  • Puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿Tiene preguntas? a continuación.

Ingredientes inactivos: almidón de maíz, croscarmelosa sódica, hipromelosa, maltodextrina, celulosa microcristalina, polidextrosa, povidona, dióxido de silicio, ácido esteárico, talco, dióxido de titanio, triglicéridos.

¿Tiene preguntas? 1-800-792-2582

Other Information

**CONTENTS SEALED: Each BACKAID white­ colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if seal appears broken or if product contents do not match product description.

  • You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients

Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
Active Ingredients (in Each Caplet)

Acetaminophen, 500 mg

Caffeine, 75 mg


Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with

  • backache
  • muscular aches
  • headache
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50567-7 (50567-7)

When using this product, limit the use of caffeine-containing medications, foods or beverages because too mush caffeine may cause

  • nervousness
  • irritability
  • sleeplessness
  • occasional rapid heartbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease.

Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Analgesic (pain reliever)

Analgesic aid

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • Read all package directions and warnings before use. Use only as directed.
  • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
  • Do not exceed recommended dosage.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.
Questions?

1-800-792-2582.

Package Insert (Package insert)

New & Improved Formula

Maximum Strength

BACKAID

6 Hour Formula

Acetaminophen + Caffeine

  • Eases Pain of Inflammation
  • Relieves Backache and Sciatica Pain

Active ingredients: Each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and caffeine anhydrous 75 mg (analgesic aid).

Uses: For the temporary relief of minor aches and pains associated with • backache • muscular aches • headache

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets in 24 hours, which is the maximum dally amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, limit the use of caffeine-containing medications, foods or beverages because too much cafeine may cause

  • nervousness
  • irritability
  • sleeplessness
  • occassional rapid heatbeat

The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or welling is present
  • any new symptoms appear

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

  • Read all package directions and warnings before use. Use only as directed.
  • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.
  • Do not exceed recommended dosage.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.

Other information:

**CONTENTS SEALED: Each BACKAID white colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing or in a bottle with a safety seal under the cap. Do not use if seal appears broken or if product contents do not match product description. • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Questions? 1-800-792-2582

Fórmula nueva y mejorada

Maxima concentración

BACKAID

Fórmula de 6 horas

Acetaminofeno + cafeina

  • Alivia el dolor de la inflamación
  • Alivia el dolor de espalda y el dolor ciático

Ingredientes activos: Cada comprimido oblongo contiene: 500 mg de acetaminofeno (un analgésico, alivia el dolor) y 75 mg de cafeína anhidra (ayuda analgésica).

Usos: Para el alivio temporal de dolores menores asociados con

  • dolor de espalda
  • dolores musculares
  • dolor de cabeza

Advertencias:

Advertencia hepática: Este producto contiene acetaminofeno. Puede producirse un daño hepático grave si usted toma:

  • más de 6 comprimidos oblongos en 24 horas, que es la cantidad diaria máxima
  • otros fármacos que contienen acetaminofeno al mismo tiempo
  • 3 o más bebidas alcohólicas cada día mientras usa este producto.

Alerta de alergias: El acetaminofeno puede causar reacciones graves en la piel. Los síntomas pueden incluir:

  • enrojecimiento de la piel
  • ampollas
  • sarpullido

Si se produce una reacción en la piel, deje de usar el producto y busque ayuda médica de inmediato.

No lo use

  • con ningún otro fármaco que contenga acetaminofeno (de venta con receta o sin ella). Si no está seguro respecto de si un fármaco contiene acetaminofeno o no, pregúntele a un médico o farmacéutico.

Pregúntele a un médico antes de usarlo si tiene enfermedad hepática.

Pregúntele a un médico o farmacéutico antes de usarlo si está tomando el fármaco anticoagulante warfarina.

Cuando use este producto, limite el uso de medicamentos, alimentos o bebidas que contengan cafeína ya que demasiada cafeína puede provocar:

  • nerviosismo
  • irritabilidad
  • insomnio
  • latidos cardíacos rápidos ocasionales

La dosis recomendada de este producto contiene aproximadamente la misma cantidad de cafeína que una taza y media de café.

Deje de usarlo y consulte a un médico si

  • el dolor empeora o dura más de 10 días
  • la fiebre empeora o dura más de 3 días
  • aparece enrojecimiento o hinchazón
  • se presentan síntomas nuevos.

Si está embarazada o está amamantando, consulte a un profesional de la salud antes de usarlo.

Manténgalo fuera del alcance de los niños. En caso de sobredosis, obtenga ayuda médica o comuníquese de inmediato con un centro de toxicología. La atención médica inmediata es fundamental tanto para los adultos como para los niños, incluso si no observa signos ni síntomas.

Indicaciones:

  • Lea todas las indicaciones y advertencias del envase antes de usarlo. Usar según indicaciones.
  • Adultos: Dos (2) comprimidos oblongos con un vaso lleno de agua cada 6 horas mientras los síntomas persisten, sin exceder las 3 dosis (6 comprimidos oblongos) en 24 horas, o según lo indique un médico.
  • No exceda la dosificación recomendada.
  • Para uso por parte de adultos normalmente sanos únicamente.
  • Las personas menores de 18 años deben usarlo solo según las indicaciones de un médico.

Información adicional:

  • **CONTENIDO SELLADO: Cada comprimido de BACKAID, de forma ovalada y color blanco, lleva la marca identificatoria “ALVA” y está sellado en un blíster de plástico transparente con un recubrimiento posterior de papel/aluminio, o en un frasco con un sello de seguridad debajo de la tapa. No lo use si el sello parece estar roto o si el contenido del producto no coincide con la descripción del producto.
  • Puede informar efectos secundarios graves al número de teléfono que aparece en la sección ¿Tiene preguntas? a continuación.

Ingredientes inactivos: almidón de maíz, croscarmelosa sódica, hipromelosa, maltodextrina, celulosa microcristalina, polidextrosa, povidona, dióxido de silicio, ácido esteárico, talco, dióxido de titanio, triglicéridos.

¿Tiene preguntas? 1-800-792-2582

Other Information (Other information)

**CONTENTS SEALED: Each BACKAID white­ colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if seal appears broken or if product contents do not match product description.

  • You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients (Inactive ingredients)

Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen, 500 mg

Caffeine, 75 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)