Label: ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet
- NDC Code(s): 55319-680-10
- Packager: FAMILY DOLLAR
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 12, 2023
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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.
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Allergy alert:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
• hives • facial swelling • asthma (wheezing) • shock - 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
• 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?
- PDP
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
acetaminophen, aspirin and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-680 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 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:55319-680-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214039 09/01/2023 Labeler - FAMILY DOLLAR (024472631)