Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet, film coated
- NDC Code(s): 0363-0428-08, 0363-0428-12, 0363-0428-57
- Packager: Walgreen Company
- 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 November 16, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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:
- blisters
- rash
- skin reddening
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 heart beat.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Walgreens
Compare to Excedrin® Tension
Headache Caplets active ingredients††NDC 0363-0428-12
Tension Headache Relief
ACETAMINOPHEN / CAFFEINE / PAIN RELIEVER
ASPIRIN FREE
CAPLETS
100 CAPLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSINGWalgreens Pharmacist Recommended
Walgreens Pharmacist Survey
††This product is not manufactured or distributed by
GSK group of companies, owner of the registered
trademark Excedrin® Tension Headache Caplets.50844 REV1119A42812
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens 100% SATISFACTION GUARANTEED
Walgreens.com ©2018 Walgreen Co.44-428
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INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0428 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 ALUMINUM LAKE (UNII: ZK64F7XSTX) TALC (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) CROSPOVIDONE (UNII: 2S7830E561) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color red Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;428 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0428-12 1 in 1 CARTON 01/17/2007 05/18/2023 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:0363-0428-08 1 in 1 CARTON 01/17/2007 07/15/2018 2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:0363-0428-57 1 in 1 CARTON 01/17/2007 02/07/2021 3 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/17/2007 05/18/2023 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(0363-0428) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(0363-0428) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(0363-0428) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(0363-0428)