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Generic: acetaminophen is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain


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Drug Facts

Active Ingredient (in Each Capsule)


Acetaminophen 325 mg

Purpose


Pain reliever/ fever reducer

Uses

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

Warnings


Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION


Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if the user is 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 SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children.

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 right away. 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 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor

Children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels 24 hours
  • do not use for more than 5 days unless directed by a doctorr

children under 6 years
  • ask a doctor

Other Information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients


FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink.

Manufactured by:Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.Wuhan, Hubei430206, China

Principal Display Panel - Shipping Label


ACETAMINOPHEN CAPSULES, 325 mg

Quantity : 5000 CapsulesNDC. No : 53345-010-01

IMPORTANT:

Inspect immediate upon receipt.This is a bulk shipment intended for further processing only.Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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