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

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg


Medication Information

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.

Active Ingredient

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
Purpose

Pain reliever/fever reducer

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

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

Description

Acetaminophen 325 mg

Label

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

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.

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

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.

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Pain reliever/fever reducer

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

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

Label

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

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.

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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