Label: EXCEDRIN TENSION HEADACHE- acetaminophen, caffeine tablet, film coated
- NDC Code(s): 0067-8139-01, 0067-8139-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 13, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- more than 6 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
EXCEDRIN
TENSION HEADACHE
ASPIRIN-FREE
Acetaminophen 500 mg, Caffeine 65 mg
Pain Reliever / Pain Reliever Aid
ACTUAL SIZE
24 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER SAFETY SEAL UNDER CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201976
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INGREDIENTS AND APPEARANCE
EXCEDRIN TENSION HEADACHE
acetaminophen, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8139 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 BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED Score no score Shape OVAL ((Caplet)) Size 17mm Flavor Imprint Code ETH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8139-01 1 in 1 CARTON 12/15/2016 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-8139-02 1 in 1 CARTON 12/15/2016 2 100 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 12/15/2016 Labeler - Haleon US Holdings LLC (079944263)