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EXCEDRIN TENSION HEADACHE (acetaminophine, caffeine) tablet, film coated
[Novartis Consumer Health, Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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 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 heart beat.

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 pharmacists

  • 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

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

  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important 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 Tension Headache Caplets

INGREDIENTS & APPEARANCE

EXCEDRIN  TENSION HEADACHE
acetaminophine, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-2045
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 
STARCH, CORN 
SORBITAN MONOLAURATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (Red) Scoreno score
ShapeCAPSULE (Capsule shaped Tablet) Size18mm
FlavorImprint Code ETH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2045-241 in 1 CARTON
124 in 1 BOTTLE
2NDC:0067-2045-022 in 1 POUCH
3NDC:0067-2045-07250 in 1 BOTTLE
4NDC:0067-2045-501 in 1 CARTON
450 in 1 BOTTLE
5NDC:0067-2045-771 in 1 CARTON
5250 in 1 BOTTLE
6NDC:0067-2045-911 in 1 CARTON
6100 in 1 BOTTLE
7NDC:0067-2045-94100 in 1 BOTTLE
8NDC:0067-2045-831 in 1 CARTON
8125 in 1 BOTTLE
9NDC:0067-2045-84125 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/31/2005
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 1/2010
 
Novartis Consumer Health, Inc.