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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS ?
    15. PRINCIPAL DISPLAY PANEL

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Granules India Limited. 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.

Active Ingredient (In Each Caplet)



Acetaminophen USP,  650 mg


Purpose



Pain reliever/fever reducer


Uses



For Arthritis Pain label
• temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
• temporarily reduces fever

For Muscle Aches & Pain label
• temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • minor pain of arthritis
    • toothache
    • premenstrual and menstrual cramps
    • headache
    • the common cold
• temporarily reduces fever



Warnings




Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take
• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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 drugs 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.


Ask A Doctor Before Use If You Have



liver disease.


Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin.


Stop Use And Ask 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.


If Pregnant Or Breast-Feeding



ask a health professional before use.


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



For Arthritis Pain Label
•  do not take more than directed (see overdose warning)


 adults • take 2 caplets every 8 hours with water
 • swallow whole; do not crush, chew, split or dissolve
 • do not take more than 6 caplets in 24 hours
 • do not use for more than 10 days unless directed by a doctor 
 under 18 years
 of age 		 • ask a doctor


For Muscle Ache and Pain label
• do not take more than directed (see overdose warning)


 adults and children
12 years of age and over 		 • take 2 caplets every 8 hours with water
 • swallow whole; do not crush, chew, split or dissolve
 • do not take more than 6 caplets in 24 hours
 • 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 foil inner seal is broken or missing.


Inactive Ingredients



hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid


Questions Or Comments ?



Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.


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acetaminophen-650mg - acetaminophen 650mg label4

acetaminophen-650mg - acetaminophen 650mg label4


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