Buscapina

Buscapina
SPL v4
SPL
SPL Set ID 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b
Route
ORAL
Published
Effective Date 2018-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (60 mg) Pyrilamine (15 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Microcrystalline Cellulose Starch, Pregelatinized Corn Titanium Dioxide Talc Hypromelloses Polyethylene Glycol, Unspecified Povidone

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-05

Description

Buscapina

Purpose

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief


Medication Information

Purpose

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

Description

Buscapina

Uses
  • For the temporary relief of these symptoms associated with menstrual periods
  • Cramps
  • Bloating
  • Water- weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue
Warnings

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

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

Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Directions
  • Do not exceed recommended dosage.
  • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
  • Children under 12 years: Consult a doctor
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Drug Facts

Buscapina

Other Information
  • Store at room temperature 68-77° F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Inactive Ingredients
  • Colloidal silicon dioxide
  • Hypromellose
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl pyrrolidone
  • Pregelatinized starch
  • Titanium dioxide
  • Talc
Questions Or Comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST

PLEASE REFER TO LEAFLET FOR INSTRUCTIONS IN SPANISH

CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

When Using This Product
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee.
Principal Display Panel 24

NDC 69729-130-24

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Malete 15 mg

Pain Reliever

  • Cramps/ Cólicos
  • Bloatinng/ Hinchazón
  • Fatigue/ Fatiga
  • Headache/ Dolor de cabeza
  • Backache/ Dolor de espalda

Licenced by:

Gute Besserung Hauser LLC

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Stop Use and Ask A Doctor If
  • new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
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 (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 60mg, and Pyrilamine maleate 15mg 

Ask A Doctor Before Use If You Have
  • Liver disease
  • Glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

Structured Label Content

Uses
  • For the temporary relief of these symptoms associated with menstrual periods
  • Cramps
  • Bloating
  • Water- weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue
Purpose

Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

Warnings

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

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

Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

Directions
  • Do not exceed recommended dosage.
  • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
  • Children under 12 years: Consult a doctor
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Drug Facts

Buscapina

Other Information
  • Store at room temperature 68-77° F (20-25°C)
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Inactive Ingredients (Inactive ingredients)
  • Colloidal silicon dioxide
  • Hypromellose
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl pyrrolidone
  • Pregelatinized starch
  • Titanium dioxide
  • Talc
Questions Or Comments? (Questions or comments?)

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST

PLEASE REFER TO LEAFLET FOR INSTRUCTIONS IN SPANISH

CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL

When Using This Product (When using this product)
  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee.
Principal Display Panel 24 (Principal display panel 24)

NDC 69729-130-24

Buscapina

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine Malete 15 mg

Pain Reliever

  • Cramps/ Cólicos
  • Bloatinng/ Hinchazón
  • Fatigue/ Fatiga
  • Headache/ Dolor de cabeza
  • Backache/ Dolor de espalda

Licenced by:

Gute Besserung Hauser LLC

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

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 60mg, and Pyrilamine maleate 15mg 

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Liver disease
  • Glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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