Excedrin Extra Strength Geltabs

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, ASPIRIN 250mg, CAFFEINE 65mg
Labeler: Novartis Consumer Health, Inc
NDC Code: 0067-2021

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.

Drug Facts

Active ingredients (in each geltab)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-infammatory drug

Purposes

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 geltabs 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 an NSAID, which may cause severe 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 prescription or nonprescription NSAIDs (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 acetaminophen, 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 a 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
  • you have asthma

Ask a doctor or pharmacist before use if you are taking
  • 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 a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of 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.

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

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, D&C yellow #10 lake, disodium EDTA, FD&C blue #1 lake, FD&C red #40 lake, ferric oxide, gelatin, glycerin, hydroxypropylcellulose, hypromellose, light mineral oil, maltitol solution, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propylene glycol, propyl gallate, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Package/Label Principal Display Panel

NDC 0067-2021-24

See new warnings information

EXCEDRIN

EXTRA
STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

24 GELTABS

EXCEDRIN  EXTRA STRENGTH GELTABS
acetaminophen, asprin, caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2021
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 
D&C YELLOW NO. 10 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FERRIC OXIDE RED 
GELATIN 
GLYCERIN 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
LIGHT MINERAL OIL 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 20 
POVIDONE 
PROPYLENE GLYCOL 
PROPYL GALLATE 
DIMETHICONE 
SORBITAN MONOLAURATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREEN (dark green) , WHITEScoreno score
ShapeROUNDSize18mm
FlavorImprint CodeE
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-2021-241 BOTTLE in 1 CARTON
124 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/13/2011
Labeler - Novartis Consumer Health, Inc (879821635)

Revised: 08/2011
 
Novartis Consumer Health, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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