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  5. Label Information: Good Sense Pain Relief

FDA Label for Good Sense 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. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. HOW SUPPLIED
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Sense Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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



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

    • These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


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 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

  • adults and children 12 years and over

    •••

    children

    6-11 years

    •••doctor

    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


How Supplied



Acetaminophen 325 mg: color white, shape round (beveled edge) and the imprint code 325MG;L403.

NDC: 71335-2574-1: 20 Tablets in a BOTTLE

NDC: 71335-2574-2: 100 Tablets in a BOTTLE

NDC: 71335-2574-3: 30 Tablets in a BOTTLE

NDC: 71335-2574-4: 2 Tablets in a BOTTLE

NDC: 71335-2574-5: 6 Tablets in a BOTTLE

NDC: 71335-2574-6: 10 Tablets in a BOTTLE

NDC: 71335-2574-7: 60 Tablets in a BOTTLE

NDC: 71335-2574-8: 90 Tablets in a BOTTLE

NDC: 71335-2574-9: 40 Tablets in a BOTTLE

NDC: 71335-2574-0: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504


Package Label.Principal Display Panel



Acetaminophen 325 mg Tablet

Label - lbl713352574

Label - lbl713352574


* Please review the disclaimer below.