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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSAGE
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. INACTIVE INGREDIENT
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Time Cap Labs 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.

Otc - Active Ingredient



Active ingredient (in each tablet)Acetaminophen 325 mg

Otc - Purpose



PurposePain reliever/fever reducer

Indications & Usage



Uses
  • 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

Warnings



Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you have:
  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Otc - Do Not Use



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 you have
  • liver disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

Otc - Stop Use



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.

Overdosage



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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration



Directions
  • do not take more than directed (see overdose warning)
    • adults and children 12 years and over
    • take 2 tablets (1,000 mg) every 6 hours while symptoms last
    • do not take more than 6 tablets (3,000 ng) 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
      • do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Storage And Handling



Other information
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredient



Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid*may contain this ingredient

Package Label.Principal Display Panel



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* Please review the disclaimer below.