Otc - Active Ingredient
Active ingredients (in each caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine Maleate 15 mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Buscapina (NDC 69729-131). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine Maleate 15 mg
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 • headache • backache • fatigue
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
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
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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
Other information
Inactive ingredients
Colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose, microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions or comments?
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Monday through Friday 9AM - 5PM EST
Buscapina
Acetaminophen, Caffeine, Pyrilamine Maleate Tablets
NDC 69729-131-72
Acetaminophen 500 mg . . . . . . . Pain reliever
Caffeine 60 mg . . . . . . . . . . . . . . Diuretic
Pyrilamine Maleate 15 mg . . . . . Antihistamine
Dolor de Cabeza
Dolor de Espalda
144 Caplets
72 packs of 2 Caplets
Made in India
Exclusively distributed by:
OPMX
San Diego, CA 92154
Phone: 619-600-5632
* Please review the disclaimer below.