Label: BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated
- NDC Code(s): 69729-132-06
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 3, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
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Warnings
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Buscapina 6 caplets
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INGREDIENTS AND APPEARANCE
BUSCAPINA
acetaminophen, caffeine, pyrilamine maleate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-132 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TALC (UNII: 7SEV7J4R1U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score score with uneven pieces Shape CAPSULE Size 17mm Flavor Imprint Code V1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-132-06 3 in 1 CARTON 09/04/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/04/2023 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Vovantis Laboratories Private Limited 650502151 manufacture(69729-132)
