drug facts

drug facts
SPL v1
SPL
SPL Set ID de064623-31ad-4d37-8025-922d39624f27
Route
oral
Published
Effective Date 2014-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
starch, corn hypromelloses polyethylene glycols stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph not final active Since 2014-12-17

Purpose

Analgesic/Antipyretic

Description

Acetaminophen 500 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Uses

temporary relief of minor aches and pains associated with common cold headache toothache

muscular aches backache arthritis menstrual cramps and reduction of fever

Purpose

Analgesic/Antipyretic

Directions

Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone, and sodium starch glycolate.

Description

Acetaminophen 500 mg

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

Active Ingredient

Acetaminophen 500 mg

Stop Use and Ask A Doctor If

symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare

sensitivity reaction occurs You may report side effects to 1-888-952-0050

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have

liver disease

Package/label Principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You

are taking the blood thinning drug warfarin


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Uses

temporary relief of minor aches and pains associated with common cold headache toothache

muscular aches backache arthritis menstrual cramps and reduction of fever

Purpose

Analgesic/Antipyretic

Directions

Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone, and sodium starch glycolate.

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

Active Ingredient (Active ingredient)

Acetaminophen 500 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare

sensitivity reaction occurs You may report side effects to 1-888-952-0050

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

ask a health professional before use

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

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

liver disease

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

are taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)