EXCEDRIN TENSION HEADACHE PAIN RELIEVER- acetaminophen and caffeine tablet, film coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg (formulated with 65 mg caffeine)

Purpose

Pain reliever

Uses

● temporarily relieves minor aches and pains 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:

Commended 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 us 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

carnauba wax, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate acid, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-468-7746

Package/Label Principal Display Panel

100 ct PDP
EXCEDRIN  TENSION HEADACHE PAIN RELIEVER
acetaminophen and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8119
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code ETH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8119-241 in 1 CARTON06/27/201404/30/2018
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-8119-911 in 1 CARTON06/27/201404/30/2018
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/27/201404/30/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC