EXCEDRIN TENSION HEADACHE - acetaminophen and caffeine tablet, film coated 
Novartis Consumer Health, Inc.

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Drug Facts

Active ingredient

Acetaminophen 500 mg

Caffeine 65 mg

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:

• headache • muscular aches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 tablets 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 heart beat.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacists

Stop use and ask a doctor if

Pregnancy 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

Other information

Inactive ingredients

benzoic acid, carnauba wax, D&C red # 27 lake, D&C yellow # 10 lake, FD&C blue # 1 lake, FD&C red # 40, hypromellose, light mineral oil, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments

1-800-468-7746

Distr. By:  

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Visit us at www.excedrin.com

Principal Display

Excedrin TH Tablets

Tension Headache


EXCEDRIN  TENSION HEADACHE
acetaminophine, caffeine   tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0067-2041
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
D&C RED NO. 27 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HYPROMELLOSE 
LIGHT MINERAL OIL 
MAGNESIUM STEARATE 
POLYSORBATE 20 
POVIDONE 
PROPYLENE GLYCOL 
SORBITAN MONOLAURATE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (Red) Score no score
ShapeROUND (Tablet Shape) Size11mm
FlavorImprint Code ETH
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10067-2041-241 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (0067-2041-24)
20067-2041-501 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0067-2041-50)
30067-2041-771 BOTTLE In 1 CARTONcontains a BOTTLE
3250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0067-2041-77)
40067-2041-911 BOTTLE In 1 CARTONcontains a BOTTLE
4100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0067-2041-91)
50067-2041-101 BOTTLE In 1 CARTONcontains a BOTTLE
510 TABLET In 1 BOTTLEThis package is contained within the CARTON (0067-2041-10)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/31/200507/01/2011

Labeler - Novartis Consumer Health, Inc. (879821635)
Revised: 01/2010Novartis Consumer Health, Inc.