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  5. Label Information: Pluspharma Extra Strength Pain Reliever,fever Reducer 500 Mg

FDA Label for Pluspharma Extra Strength Pain Reliever,fever Reducer 500 Mg

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL

Pluspharma Extra Strength Pain Reliever,fever Reducer 500 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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 500 mg


Purposes



Pain reliever/fever reducer


Uses



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

Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen 
  • •3 or more alcoholic drinks every day while using this product

Do Not Use



  • •with any other drug containing acetaminophen (prescription or non prescription). 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

Ask A Doctor Before Use If You Have



liver disease.


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin.


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 - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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)

Adults and children 12 years and over:

  • •take 2 tablets every 6 hours while symptoms last
  • •do not take more than 6 tablets in 24 hours unless directed by a doctor
  • •do not take for more than 10 days unless directed by a doctor.

    • Children under 12 years: ask a doctor.


Other Information



  • •Do not use if imprinted safety seal under cap is broken or missing
  • •Store at room temperature

Inactive Ingredients



Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.


Questions?



If you have any questions or comments, or to report an adverse event, please contact  (800) 795-9775.


Principal Display Panel



PlusPHARMA

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

See New Warnings Information and Directions

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®

40 TABLETS 500 mg each

63187-293-40 - ferefhted

63187-293-40 - ferefhted


* Please review the disclaimer below.