tension headache relief (acetaminophen 500mg and caffeine 65mg)

tension headache relief (acetaminophen 500mg and caffeine 65mg)
SPL v7
SPL
SPL Set ID ac9efd62-8fee-b777-e053-2995a90a3783
Route
oral
Published
Effective Date 2023-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) caffeine (65 mg)
Inactive Ingredients
croscarmellose sodium polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc microcrystalline cellulose silicon dioxide starch, corn titanium dioxide d&c red no. 27 fd&c blue no. 2 magnesium stearate stearic acid fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: capsule Color: red Size: 28 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-08-03

Purpose

Acetaminophen 500mg............................................................................................................Pain reliever Caffeine 65mg................................................................................................................... Pain reliever aid

Description

Acetaminophen 500mg Caffeine 65 mg


Medication Information

Purpose

Acetaminophen 500mg............................................................................................................Pain reliever

Caffeine 65mg................................................................................................................... Pain reliever aid

Directions

Do not use more than directed

■adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours

■chlidren under 12 years: ask a doctor

Other Information

•store at 20°-25°C (68°-77°F)

•close cap tightly after use

•read all product information before using.

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

Description

Acetaminophen 500mg Caffeine 65 mg

Principal Display Panel

Uses:

temporarily relieves minor aches and pains due to:

•headache

•muscular aches

Pregnancy

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

Warnings:

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.

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

Caffeine warning:The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

•if you are allergic to acetaminophen

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

Ask Doctor:

Ask a doctor before use if

•you have liver disease

Ask Doctor/pharmacist:

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9AM to 5PM EST.

Stop Use and Ask Doctor If 

■any new symptoms occur

■painful area is red or swollen

■pain gets worse or lasts for more than 10 days

■fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients  (in Each Caplet)

Acetaminophen 500mg

Caffeine 65 mg


Structured Label Content

Purpose

Acetaminophen 500mg............................................................................................................Pain reliever

Caffeine 65mg................................................................................................................... Pain reliever aid

Directions (DIRECTIONS)

Do not use more than directed

■adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours

■chlidren under 12 years: ask a doctor

Other Information (OTHER INFORMATION)

•store at 20°-25°C (68°-77°F)

•close cap tightly after use

•read all product information before using.

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Uses:

temporarily relieves minor aches and pains due to:

•headache

•muscular aches

Pregnancy (PREGNANCY)

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

Warnings:

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.

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

Caffeine warning:The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

•if you are allergic to acetaminophen

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

Ask Doctor:

Ask a doctor before use if

•you have liver disease

Ask Doctor/pharmacist: (ASK DOCTOR/PHARMACIST:)

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-732-698-5070 Monday through Friday 9AM to 5PM EST.

Stop Use and Ask Doctor If  (Stop use and ask doctor if )

■any new symptoms occur

■painful area is red or swollen

■pain gets worse or lasts for more than 10 days

■fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients  (in Each Caplet) (Active Ingredients  (in each caplet))

Acetaminophen 500mg

Caffeine 65 mg


Advanced Ingredient Data


Raw Label Data

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