Your browser does not support JavaScript! EXCEDRIN BACK AND BODY (ACETAMINOPHEN, ASPIRIN) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]
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EXCEDRIN BACK AND BODY (acetaminophen, aspirin) tablet, film coated
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

TAMPER-EVIDENT BOTTLE

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

IS BROKEN OR MISSING

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

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 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

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

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 Back & Body Extra Strength

Excedrin Back & Body Extra Strength

EXCEDRIN  BACK AND BODY
acetaminophen, aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-6238
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (Bi-layer Light & Dark Green) Scoreno score
ShapeCAPSULE (capsule-shaped tablet) Size18mm
FlavorImprint Code EBB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6238-061 in 1 CARTON
16 in 1 BOTTLE
2NDC:0067-6238-241 in 1 CARTON
224 in 1 BOTTLE
3NDC:0067-6238-501 in 1 CARTON
350 in 1 BOTTLE
4NDC:0067-6238-911 in 1 CARTON
4100 in 1 BOTTLE
5NDC:0067-6238-771 in 1 CARTON
5250 in 1 BOTTLE
6NDC:0067-6238-94100 in 1 BOTTLE
7NDC:0067-6238-07250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/15/2010
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 1/2010
 
Novartis Consumer Health, Inc.

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