EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin and caffeine tablet, film coated 
Novartis Consumer Health, Inc.

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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Active ingredient (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • a cold
    • arthritis
    • muscular aches
    • sinusitis
    • toothache
    • premenstrual & menstrual cramps

Warnings

Reye’s syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning:

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

  • more than 8 tables 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

 

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

 

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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
  • 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 Doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn

    you have high blood pressure, heart disease, liver cirrhosis. or kidney disease

  • you are taking a diuretic
  • high blood pressure
  • you have asthma

Ask a doctor or pharmacist before use

  • any other drug containing an NSAID (prescription or nonprescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

 

Stop use and ask doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs os stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • 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
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

Overdose Warning

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 (see Overdose Warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 tablets  every 6 hours; not more than 8 tables  in 24 hours
  • children under 12 years: ask a doctor

Other information 

  • store at controlled room temperature 200 -  250 C (680 -  770 F)
  • read all product information before using. Keep this box for important information

 

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Principal Display Panel

Excedrin E.S. Tablets

EXCEDRIN  EXTRA STRENGTH
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
DIMETHICONE 410 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSE 2910 (15 MPA.S) 
LIGHT MINERAL OIL 
POLYSORBATE 20 
POVIDONE 
PROPYLENE GLYCOL 
SORBITAN MONOLAURATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-2030-061 in 1 CARTON
16 in 1 BOTTLE, PLASTIC
2NDC:0067-2030-081 in 1 CARTON
28 in 1 BOTTLE, PLASTIC
3NDC:0067-2030-101 in 1 CARTON
310 in 1 BOTTLE, PLASTIC
4NDC:0067-2030-241 in 1 CARTON
424 in 1 BOTTLE, PLASTIC
5NDC:0067-2030-501 in 1 CARTON
550 in 1 BOTTLE, PLASTIC
6NDC:0067-2030-911 in 1 CARTON
6100 in 1 BOTTLE, PLASTIC
7NDC:0067-2030-94100 in 1 BOTTLE, PLASTIC
8NDC:0067-2030-831 in 1 CARTON
8125 in 1 BOTTLE, PLASTIC
9NDC:0067-2030-921 in 1 CARTON
9200 in 1 BOTTLE, PLASTIC
10NDC:0067-2030-5150 in 1 BOX, UNIT-DOSE
10NDC:0067-2030-022 in 1 PACKET
11NDC:0067-2030-07250 in 1 BOTTLE, PLASTIC
12NDC:0067-2030-771 in 1 CARTON
12250 in 1 BOTTLE, PLASTIC
13NDC:0067-2030-331 in 1 CARTON
13300 in 1 BOTTLE, PLASTIC
14NDC:0067-2030-57300 in 1 BOTTLE
15NDC:0067-2030-301 in 1 CARTON
1530 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/27/2006
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIBusiness Operations
Novartis Consumer Health129836151MANUFACTURE, ANALYSIS

Revised: 06/2011
 
Novartis Consumer Health, Inc.