Label: TENSION HEADACHE RELIEF- acetaminophen-caffeine tablet, coated
- NDC Code(s): 11673-839-01
- Packager: TARGET CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 16, 2019
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
WARNINGS
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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skin reddening
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blisters
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rashIf a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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more than 6 caplets in 24 hours, which is the maximum daily amount
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with other drugs containing acetaminophen
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3 or more alcoholic drinks every day while using this productCaffeine 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen-caffeine tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-839 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 D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CARNAUBA WAX (UNII: R12CBM0EIZ) TALC (UNII: 7SEV7J4R1U) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color red Score no score Shape OVAL ((Caplet)) Size 17mm Flavor Imprint Code TCL373 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-839-01 100 in 1 CARTON; Type 0: Not a Combination Product 02/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/04/2020 Labeler - TARGET CORPORATION (006961700) Registrant - TIME CAP LABORATORIES, INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(11673-839)
