194 325mg Acetaminophen Tablets

194 325mg Acetaminophen Tablets
SPL v2
SPL
SPL Set ID fc5d92c2-4bbe-8ad1-e053-6294a90a65b6
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromelloses Polyethylene Glycol, Unspecified Starch, Corn Povidone K30 Sodium Starch Glycolate Type A Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G323 Shape: round Color: white Size: 9 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses
  • for the temporary relief of minor aches and pains associated with
  • the common cold
  • the flu
  • headache
  • toothache
  • muscular aches
  • backache
  • the premenstrual and menstrual periods
  • for the minor pain from arthritis
  • to reduce fever
Label

Warnings

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

  • adult takes more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

Directions
adults and children 12 years and over
  • take 1 to 2 tablets every 4 to 6 hours while symptoms persist
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
children 6 years to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • do not take more than 5 tablets in 24 hours, unless directed by a doctor
children under 6 years
  • ask a doctor

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
Manufacture

Made in India. Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE V1 RJ23HND

Other Information
  • store between 20–25°C (68–77°F)
  • not made with Natural Rubber Latex
  • do not use if inner seal is broken or missing
Inactive Ingredients

hydroxypropylmethylcellulose, polyethylene glycol, pregelatinised starch, providone K-30, sodium starch glycolate, stearic acid

Stop Use and Ask A Doctor If
  • adult's pain gets worse or lasts more than 10 days
  • child's pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • symptoms do not improve
  • any new symptoms appear
If Pregnant of Breast Feeding,

ask a professional before use.

Keep Out of Reach of Children.

In case of 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.

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg

Ask A Doctor Before Use If the User
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If
  • the user is taking the blood thinning drug warfarin

Structured Label Content

Uses
  • for the temporary relief of minor aches and pains associated with
  • the common cold
  • the flu
  • headache
  • toothache
  • muscular aches
  • backache
  • the premenstrual and menstrual periods
  • for the minor pain from arthritis
  • to reduce fever
Label

Purpose

Pain reliever/fever reducer

Warnings

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

  • adult takes more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

Directions
adults and children 12 years and over
  • take 1 to 2 tablets every 4 to 6 hours while symptoms persist
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
children 6 years to under 12 years
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • do not take more than 5 tablets in 24 hours, unless directed by a doctor
children under 6 years
  • ask a doctor

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

Made in India. Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE V1 RJ23HND

Other Information (Other information)
  • store between 20–25°C (68–77°F)
  • not made with Natural Rubber Latex
  • do not use if inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)

hydroxypropylmethylcellulose, polyethylene glycol, pregelatinised starch, providone K-30, sodium starch glycolate, stearic acid

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • adult's pain gets worse or lasts more than 10 days
  • child's pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • symptoms do not improve
  • any new symptoms appear
If Pregnant of Breast Feeding, (If pregnant of breast-feeding,)

ask a professional before use.

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

In case of 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 325 mg

Ask A Doctor Before Use If the User (Ask a doctor before use if the user)
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • the user is taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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