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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN 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 A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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

Warnings


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
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Liver Warning



This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 drugs 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 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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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



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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
 children 6 years to under 12 years
  •  take 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 doctor
 children under 6 years    ask a doctor


Other Information



  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing

Inactive Ingredients



povidone, pregelatinized starch, sodium starch glycolate, stearic acid


Questions Or Comments?



1-888-333-9792


Principal Display Panel



SPRIIT 360

REGULAR STRENGTH 

PAIN RELIEVER

ACETAMINOPHEN 325 mg

PAIN RELIEVER / FEVER REDUCER

100 TABLETS


* Please review the disclaimer below.