Label: ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG tablet, film coated
- NDC Code(s): 71679-307-00, 71679-307-03
- Packager: Health Pharma USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 8, 2026
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Active ingredient (in each caplet)
Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg.......................................................................................................Pain reliever
Aspirin 250 mg (NSAID)*....................................................................................................Pain reliever
Caffeine 65 mg..............................................................................................................Pain reliever aid*nonsteroidal anti-inflammatory drug
- Purpose
- Uses
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Warning
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should
not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor
because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin
may cause a severe allergic reaction, which may include: ■ hives ■ shock ■ facial swelling ■ asthma (wheezing).
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 tablets
in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic
drinks every day while using this product. Stomach bleeding warning: This product contains an NSAID, which may cause
severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleeding
problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or
nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while
using this product ■ take more or for a longer time directed Caffeine warning: The recommended dose of this
product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or
beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heartbeat. - do not use
- Ask a doctor before use if you have
- Ask your doctor or pharmacist before use if you are
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Stop use and ask doctor if
Stop use and ask a doctor if■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ have
bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ an allergic reaction occurs. Seek
medical help right away. ■ any new symptoms appear ■ ringing in the ears or loss of hearing occurs ■ pain gets
worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ painful area is red or swollen - If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other Information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG
acetaminophen 250 mg aspirin 250 mg caffeine 65 mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) ACETAMINOPHEN (UNII: 362O9ITL9D) 250 mg CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code HH6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71679-307-00 30000 in 1 DRUM; Type 0: Not a Combination Product 03/07/2024 2 NDC:71679-307-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/07/2024 Labeler - Health Pharma USA LLC (080804485) Registrant - Health Pharma USA LLC (080804485)


