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  5. Label Information: Pain Relief

FDA Label for Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE USER
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution 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 Tablet)



Acetaminophen 325 mg


Purpose



Pain reliever/fever reducer


Uses



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

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • •adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •child takes more than 5 doses in 24 hours
  • •taken with other drugs containing acetaminophen
  • •adult has 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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If The User



  • •has liver disease
  • •is a child with pain of arthritis

Ask A Doctor Or Pharmacist Before Use If The User Is



taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • •pain gets worse or lasts for more than 10 days (for adults) or 5 days (for children)
  • •fever gets worse or lasts for more than 3 days
  • •new symptoms occur
  • •redness or swelling is present

    • These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



  • •do not take more than directed (see overdose warning)
    • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctortake 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  • doctor

    adults and children 12 years and over

    •••

    children

    6-11 years

    ••• 

    children under

    6 years

    ask a doctor


Inactive Ingredients



croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient


Questions Or Comments?



1-800-719-9260


Principal Display Panel



meijer®

REGULAR STRENGTH

Pain Relief

COMPARE TO TYLENOL® ACTIVE INGREDIENT

ACETAMINOPHEN

PAIN RELIEVER | FEVER REDUCER

For Ages 6 Years And Over

Actual Size

100 TABLETS

325 mg each

Pain Relief Carton - 403786EC4

Pain Relief Carton - 403786EC4


* Please review the disclaimer below.