Label: TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet, film coated
- NDC Code(s): 68210-4184-3
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 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
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.
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 a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
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- Pouch
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INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4184 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape CAPSULE Size 18mm Flavor Imprint Code S431 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4184-3 30 in 1 POUCH; Type 0: Not a Combination Product 11/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/22/2021 Labeler - Spirit Pharmaceuticals LLC (179621011)