EXCEDRIN TENSION HEADACHE- acetaminophen, caffeine tablet, film coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pain due to:
headache
muscular aches

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
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
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 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

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 a doctor before use if

you have liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

any new symptoms occur
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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
children under 12 years: ask a doctor

Other information

store at 20°-25°C (68°-77°F)
close cap tightly after use
read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-468-7746

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

Excedrin Tension Headache 24 ct
EXCEDRIN  TENSION HEADACHE
acetaminophen, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8139
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeOVAL ((Caplet)) Size17mm
FlavorImprint Code ETH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8139-011 in 1 CARTON12/15/2016
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-8139-021 in 1 CARTON12/15/2016
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/15/2016
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: dd87f543-c93b-4204-a601-368db2fec725
Set id: 12c074d1-81ac-47d2-8747-b018cda0058a
Version: 7
Effective Time: 20240313
 
Haleon US Holdings LLC