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EXCEDRIN

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 250

Buffered aspirin equal to 250 mg aspirin (NSAID)*

(buffered with calcium carbonate)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

EXCEDRIN Uses

  • for the temporary relief of minor aches and pains due to:
    • minor pain of arthritis
    • backache
    • muscular aches

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 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

 

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

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 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 the doctor or pharmacist before use if you are

  • 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

Pregnancy 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  caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

EXCEDRIN Other information

  • each caplet contains: calcium 80 mg
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important information.

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION”

IS BROKEN OR MISSING

 

Questions

Questions or comments? 1-800-468-7746

 

Distr. By: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20XX

Visit us at www.excedrin.com

Principal Display

EXCEDRIN
Excedrin Back & Body Extra Strength

EXCEDRIN

Acetaminophen, Aspirin TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6238
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
aspirin ASPIRIN 250 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
cellulose, microcrystalline
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
hydroxypropyl cellulose
hypromellose
maltodextrin
MEDIUM-CHAIN TRIGLYCERIDES
POLYDEXTROSE
polysorbate 80
povidone
STARCH, CORN
STEARIC ACID
talc
ZINC STEARATE

Product Characteristics

Color Size Imprint Code Shape
GREEN (Bi-layer Light & Dark Green) 18 mm EBB CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BOTTLE
2 24 in 1 BOTTLE
3 50 in 1 BOTTLE
4 100 in 1 BOTTLE
5 250 in 1 BOTTLE
6 NDC:0067-6238-94 100 in 1 BOTTLE
7 NDC:0067-6238-07 250 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-02-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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