Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet
- NDC Code(s): 84324-002-01
- Packager: NUVICARE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 20, 2024
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- Official Label (Printer Friendly)
- Active Ingredients (in each caplet)
- Purpose
- Uses:
-
Warnings:
ALLERGY ALERT:Acetaminophen may cause severe skin reactions. Symptoms may include:
•skin reddening
•blisters
•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
•no 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 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.
DO NOT USE:
•if you have ever had an allergic reaction 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. - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- Stop use and ask doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84324-002 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) TALC (UNII: 7SEV7J4R1U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color red Score no score Shape CAPSULE (Capsule shape Tablet) Size 28mm Flavor Imprint Code None Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84324-002-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/30/2024 Labeler - NUVICARE LLC (119257565) Registrant - NUVICARE LLC (119257565)

