196 Otcm00023 500mg Acetaminophen Cap

196 Otcm00023 500mg Acetaminophen Cap
SPL v2
SPL
SPL Set ID fc5f5dcf-53a6-538d-e053-6394a90a4583
Route
ORAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Stearic Acid Water Hydroxypropyl Methylcellulose Povidone K30 Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: G551 Shape: capsule Color: white Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 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
Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
  • 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.

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

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

hydroxy propyl methyl cellulose, polyethylene glycol, pregelatinised Starch, providone K-30, purified Water, sodium starch glycolate,

stearic acid

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 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 Or 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 Caplet)

Acetaminophen 500 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
Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4,000 milligrams in 24 hours, which is the maximum daily amount for this product
  • 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.

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

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

hydroxy propyl methyl cellulose, polyethylene glycol, pregelatinised Starch, providone K-30, purified Water, 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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • symptoms do not improve
  • any new symptoms appear
If Pregnant Or Breast Feeding, (If pregnant or 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 Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 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

All Sections (JSON)