Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet
- NDC Code(s): 72090-004-02
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 9, 2023
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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
•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 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. - Ask Doctor:
- ASK DOCTOR/PHARMACIST:
- Stop use and ask doctor if
- PREGNANCY
- 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:72090-004 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:72090-004-02 200 in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/03/2020 Labeler - Pioneer Life Sciences, LLC (014092742)