Label: TENSION HEADACHE PAIN RELIEVING AID- acetaminophen,caffeine tablet
- NDC Code(s): 79903-373-01
- Packager: WAL-MART STORES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets 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
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
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients carnauba wax, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
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INGREDIENTS AND APPEARANCE
TENSION HEADACHE PAIN RELIEVING AID
acetaminophen,caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-373 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) D&C RED NO. 27 (UNII: 2LRS185U6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CARNAUBA WAX (UNII: R12CBM0EIZ) TALC (UNII: 7SEV7J4R1U) POVIDONE (UNII: FZ989GH94E) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color red Score no score Shape CAPSULE (Capsule Shaped Tablet) Size 18mm Flavor Imprint Code TCL373 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-373-01 1 in 1 CARTON 04/01/2024 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/01/2024 Labeler - WAL-MART STORES INC (051957769) Registrant - TIME CAP LABORATORIES INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES INC 037052099 manufacture(79903-373)