Buscapina Tablet, Coated
FDA Label NDC 69729-132
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Buscapina (NDC 69729-132). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, liver warning:, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
| Active Ingredients (in each caplet) | Purpose |
| Acetaminophen 500mg | Pain reliever |
| Caffeine 60mg | Diuretic |
| Pyrilamine maleate 15mg | Antihistamine |
Uses
for the temporary relief of these symptoms associated with menstrual periods:
- cramps
- bloating
- water-weight gain
- headache
- backache
- muscle aches
- fatigue
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 for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy Alert
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.
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 allertgic reaction to this product or any of its ingredients
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
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 about as much caffeine as a cup of coffee.
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 Chlidren.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not exceed recommended dosage
- adults and children 12 years and over: take 2 caplets with water. Repeat every 6 hours as needed. Do not exceed 6 caplets per day.
- children under 12 years: consult a doctor
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, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
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Buscapina 6 Caplets
Buscapina
Acetaminophen, Caffeine, Pyrilamine Maleate Tablets
NDC 69729-132-06
- Cramps
- Bloating
- Fatigue
- Heacache
- Backache
6 Caplets
3 packs of 2 Caplets
* Please review the disclaimer below.
