EXCEDRIN TENSION HEADACHE- acetaminophine, 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

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
EXCEDRIN  TENSION HEADACHE
acetaminophine, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2045
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)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STARCH, CORN (UNII: O8232NY3SJ)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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 CARTON10/31/200512/31/2014
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-2045-022 in 1 POUCH; Type 0: Not a Combination Product10/31/200512/31/2014
3NDC:0067-2045-07250 in 1 BOTTLE; Type 0: Not a Combination Product10/31/200512/31/2014
4NDC:0067-2045-501 in 1 CARTON10/31/200512/31/2014
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-2045-771 in 1 CARTON10/31/200512/31/2014
5250 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-2045-911 in 1 CARTON10/31/200512/31/2014
6100 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0067-2045-94100 in 1 BOTTLE; Type 0: Not a Combination Product10/31/200512/31/2014
8NDC:0067-2045-831 in 1 CARTON10/31/200512/31/2014
8125 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0067-2045-84125 in 1 BOTTLE; Type 0: Not a Combination Product10/31/200512/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/31/200512/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC