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  5. Label Information: Certi-cet Plus Extra Strength

FDA Label for Certi-cet Plus Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (EACH TABLET)
    3. PURPOSE
    4. USES
    5. LIVER WARNING
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. KEEP OUT OF THE REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL - 500 MG TABLET POUCH BOX

Certi-cet Plus Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Certified Safety Manufacturing. 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



Drug Facts

Do not exceed recommended dosage.


Active Ingredients (Each Tablet)



Acetaminophen 500 mg


Purpose



Analgesic/Antipyretic


Uses



  • Temporary relief of minor aches and pains associated with:
    • common colds
    • headache
    • toothache
    • muscular aches
    • backache
    • arthritis
    • menstrual cramps
    • and reduction of fever.

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product.

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.

Otc - Ask Doctor



Ask a doctor before use if user has 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 Doctor If



  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs.

If Pregnant Or Breast-Feeding



  • ask a health professional before use.

Keep Out Of The Reach Of Children



  • In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions



  • Adults and children 12 years of age and older
Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.
  • Children under 12 years of age
Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information



  • store at room temperature 15-30°C (59-86°F)
  • use by expiration date on package.
  • read all product information before using.

Inactive Ingredients



  • corn starch, hydroxypropyl methylcellulose, pregelatinized starch, stearic acid, titanium dioxide.

    • May contain providone and sodium starch glycolates.


Questions?



Call 1-800-854-7474


Principal Display Panel - 500 Mg Tablet Pouch Box



Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Tylenol®

CERTI-CET
PLUS™

EXTRA STRENGTH
500 mg Acetaminophen

* Please review the disclaimer below.