Label: ACETAMINOPHEN ASPIRIN CAFFEINE- acetaminophen aspirin caffeine tablet
- NDC Code(s): 0363-9680-10, 0363-9680-24
- Packager: WALGREEN CO
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 11, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Use
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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:
- Allergy alert:
- Liver warning:
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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 than directed - Medication overuse headache warning
- Caffeine warning
- Do not use
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Ask a doctor before use if
■ you have never had migraines diagnosed by a health professional
■ you have a headache that is different from your usual migraines
■ you have the worst headache of your life
■ you have fever and stiff neck
■ you have headaches beginning after or caused by head injury, exertion, coughing or bending
■ you experienced your first headache after the age of 50
■ you have daily headaches
■ you have a migraine so severe as to require bed rest
■ you have liver disease
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ you are taking a diuretic
■ you have asthma
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ you have vomiting with your migraine headache - Ask a doctor or pharmacist before use if you are
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Stop use and ask a doctor if
Stop use and ask a doctor if
■ an allergic reaction occurs. Seek medical help right away.
■ you experience any of the following signs of stomach bleeding:
• feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better
■ your migraine is not relieved or worsens after first dose
■ new or unexpected symptoms occur
■ ringing in the ears or loss of hearing occurs - 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 ASPIRIN CAFFEINE
acetaminophen aspirin caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9680 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color white Score no score Shape CAPSULE (Capsule shaped Tablet) Size 17mm Flavor Imprint Code I1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9680-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 08/16/2021 2 NDC:0363-9680-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/16/2021 03/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214039 08/16/2021 Labeler - WALGREEN CO (008965063)