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  5. Label Information: Equate Pain Reliever Acetaminophen For Adults 250 Mg

FDA Label for Equate Pain Reliever Acetaminophen For Adults 250 Mg

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CHEWABLE BAR)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSE WARNING:
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS:
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - EQUATE PAIN RELIEVER ACETAMINOPHEN FOR ADULTS 250 MG-ORANGE VANILLA FLAVOR

Equate Pain Reliever Acetaminophen For Adults 250 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Walmart Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Chewable Bar)



Acetaminophen 250mg


Purpose



Pain reliever/fever reducer


Uses



  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings



Liver warning:this product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000mg of acetaminophen 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.

    • Allergy alert:

    acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away


Do Not Use



  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Otc - Ask Doctor



Ask a doctor before use if you have

  • liver disease
  • a sodium-restricted diet

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin


Otc - Stop Use



Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning:



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 give more than directed (see overdose warning)
    •  Age (yrs.)Dose (chewable bar)
     Adults and children 12 years and over
    • take 4 chewable bars every 6 hours while symptoms last
    • do not take more than 12 chewable bars in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
     Children under 12 years ask a doctor


Other Information



  • each chewable bar contains: potassium 5mg, sodium 16mg.
  • Store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive Ingredients:



ammonium glycyrrhizate, FD & C yellow #6, flavors, geleol mono and diglycerides, glucose syrup, hydroxypropyl betadex, maltitol solution, maltodextrin, menthol, neotame, polyethylene glycol 400, povidone, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.


Questions Or Comments?



Call 1-888-287-1915


Principal Display Panel - Equate Pain Reliever Acetaminophen For Adults 250 Mg-Orange Vanilla Flavor



NDC 79903-247-40

equate™

Compare to Tylenol ®active ingredient**

Pain Reliever Acetaminophen for Adults 250 mg

Pain Reliever/Fever Reducer

Contains No Aspirin

Soft Chew Bars

Orange Vanilla Flavor

250 mg EACH 40 CHEWABLE BARS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.


* Please review the disclaimer below.