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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 CAPLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OVERDOSAGE
    10. DOSAGE
    11. STORAGE
    12. INACTIVE INGREDIENTS
    13. INFORMATION
    14. PRINCIPAL DISPLAY PANEL - 200 CT

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Healthright Products, 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



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

Drug Facts


Active Ingredient (In Each Caplet)



Acetaminophen USP 500 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily relieves minor aches and pains due to

  • headache
  • tooth pain
  • backache
  • PMS and menstrual cramps
  • temporarily reduces fever
  • minor arthritis
  • the common cold
  • muscular pain 

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Stop Use And Ask A Doctor If



  • You are suffering from any liver disease
  • you are taking the blood thinning drug warfarin
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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



In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 


Dosage



Adults and children over 12 years of age, Take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours, unless directed by a doctor. 

Children under 12, ask a doctor. 


Storage



  • Store in a cool and dry place
  • Store between 22-25˚C (67-77˚F)

Inactive Ingredients



Micro crystalline Cellulose, Corn Starch, Sodium Starch Glycolate Type A, Sodium Lauryl sulfate, Sodium Methyl Paraben, Magnesium Stearate, Talc, Croscarmellose Sodium and polyvinyl pyrrolidone K-30


Information



Tamper Evident: Do not use if safety seal under cap is broken or missing

Swallow whole, do not crush, chew, split or dissolve


Principal Display Panel - 200 Ct



Acetaminophen Caplet, 500 mg

Pain Reliever - Fever Reducer


* Please review the disclaimer below.