Drug Facts
Drug Facts
Buscapina Tablet, Film Coated
FDA Label NDC 69729-813
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 69729-813). 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 drug facts, active ingredients (in each caplet), purpose, uses, warnings, 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
Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Purpose
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever |
| Caffeine 60 mg | Diuretic |
| Pyrilamine maleate 15 mg | Antihistamine |
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.
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
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- difficulty un rination due to the enlargement of the prostate gland
- a breathing problem sucha 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 aboout 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 Children
Keep out of reach of children
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 symtoms.
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 Ingredientes
colloidal silicon dioxide,
hydroxy propyl methyl cellulose,
magnesium stearate,
microcrystalline cellulose,
polyethylene glycol,
pregelatinized starch,
pvp K-30,
sodium starch glycolate,
stearic acid,
talc,
titanium dioxide.
Questions?
Call toll free 619-600-5632
Monday through Friday 9AM-5PM EST
PLEASE REFER TO LEAFLET INSTRUCTUIONS IN SPANISH
CONSULTE EL FOLLETO PARA INSTRUCCIONES EN ESPAÑOL
Package Label.Principal Display Panel
NDC-69729-131-24
Buscapina
Acetaminophen 500 mg
Caffeine 60mg
Pyrilamine Maleate 15mg
Pain Reliever
- Cramps/Cólicos
- Bloating/Hinchazón
- Fatigue/Fatiga
- Headache/ Dolor de cabeza
- Backache/Dolor de espalda
24 Caplets
* Please review the disclaimer below.
