Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet, film coated
- NDC Code(s): 63868-030-10
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- 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.
Updated May 26, 2020
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- Active ingredients (in each caplet)
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:
- 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 heartbeat.
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
Stop use and ask a doctor if
- new symptoms appear
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to the active ingredients in EXCEDRIN® TENSION HEADACHE*
Tension Headache Relief
Acetaminophen, 500 mg and Caffeine, 65 mg
100 Coated Caplets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by GSK group of companies, Inc., owner of the registered trademark
Excedrin® Tension Headache.
SATISFACTION 100% QC GUARANTEED
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
Quality Plus 44-428
INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen, caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-030 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) 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:63868-030-10 1 in 1 CARTON 01/17/2007 03/23/2023 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 NOT FINAL part343 01/17/2007 03/23/2023 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63868-030) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63868-030) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63868-030) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63868-030)