Acetaminophen 325 Mg - Pharbest

Acetaminophen 325 Mg - Pharbest
SPL v3
SPL
SPL Set ID 57e5fc8c-8d69-a36d-e053-2a91aa0af949
Route
ORAL
Published
Effective Date 2013-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH020 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-01-09

Description

Acetaminophen 325mg

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 325mg

Uses
  • Temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • menstrual cramps
  • Temporarily reduces fever
Section 51945-4

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product
Directions
  • do not take more than directed (see overdose warning).


Adults and children 12 years and over                     

Take 2 tablets every 4 to 6 while symptoms last.

Do not take more than 12 tablets in 24 hours.

Children 6 to under 12 years

Take 1 tablet every 4 to 6 while symptoms last.

Do not take more than 5 tablets in 24 hours.

Children under 6 years

Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

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
Questions?

Adverse drug event call: (866) 562-2756

Other Information
  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Stop Use and Ask A Doctor If
  • Pain gets worse or lasts more than 10 days in adults and children
  • 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 sign of a serious condition.

Active Ingredient (per Tablet)

Acetaminophen 325mg

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the Reach of Children.

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.


Structured Label Content

Uses
  • Temporarily relieves minor aches and pains due to
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • menstrual cramps
  • Temporarily reduces fever
Section 51945-4 (51945-4)

Purpose

Pain reliever/Fever reducer

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • Adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing acetaminophen
  • Adult has 3 or more alcoholic drinks every day while using this product
Directions
  • do not take more than directed (see overdose warning).


Adults and children 12 years and over                     

Take 2 tablets every 4 to 6 while symptoms last.

Do not take more than 12 tablets in 24 hours.

Children 6 to under 12 years

Take 1 tablet every 4 to 6 while symptoms last.

Do not take more than 5 tablets in 24 hours.

Children under 6 years

Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Questions?

Adverse drug event call: (866) 562-2756

Other Information (Other information)
  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • use by expiration date on package

Overdose Warning: (Overdose warning:)

Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients: (Inactive ingredients:)

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Pain gets worse or lasts more than 10 days in adults and children
  • 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 sign of a serious condition.

Active Ingredient (per Tablet) (Active ingredient (per tablet))

Acetaminophen 325mg

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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