1. Home
  2. Labeler Index
  3. We Care Distributors Inc.
  4. 70005-006
  5. Label Information: Acetaminophen Tablets, 500 Mg Extra Strength

FDA Label for Acetaminophen Tablets, 500 Mg Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USE
    5. DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 25 POUCH BOX

Acetaminophen Tablets, 500 Mg Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributors 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.

Other



Important: Read all product information before using. Keep this box for important information.

Drug Facts


Active Ingredient (In Each Caplet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Use



  • 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

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


Otc - Ask Doctor/Pharmacist



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



Taking more than the recommended dose (overdose) may cause liver damage. 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)
    adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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: do not use

Other Information



  • store between 20-25˚C (68-77˚F)
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date

Inactive Ingredients



hypromellose, magnesium stearate, microcrystalline cellulose , pregelatinized starch, polyethylene glycol, polyvinyl pyrrolidinone, stearic acid, talc, titanium dioxide


Questions Or Comments?



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel - 25 Pouch Box



See New Warnings Information & Directions

Compate to the Active Ingredients in
Tylenol® Extra Strength *

Acetaminophen Tablets, 500 mg
Pain Reliever - Fever Reducer


* Please review the disclaimer below.