drug facts

Composition & Product

Active Ingredients

acetaminophen (500 mg)

Inactive Ingredients

colloidal silicon dioxide starch, corn lactose magnesium stearate povidone sodium starch glycolate type a potato

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2004-03-01

Medication Information

Warnings and Precautions

Warnings Alcohol warning:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or otehr pain relievers/fever reducers.

Acetaminophen may cause liver damage

Active Ingredient

Active ingredients

Acetaminophen 500 mg

Indications and Usage

Uses

For the temporary relief of minor aches and pains associated with the common cold

headache

toothache

muscular aches

To reduce fever

Dosage and Administration

Directions

Take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years of age : consult a docto

Description

Active ingredients Acetaminophen 500 mg

Section 44425-7

Other information

Each tablet contains sodium 0.496 mg

Keep tightly closed

Store in original packaging, away from sunlight

Section 50565-1

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 children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

you need to use this product for pain for mroe than 10 days

fever lasts for more than 3 days (72 hours) or ets worse

new symptoms occur

redness or swelling is present (these could be signs of a serious condition)

Section 50570-1

Do not use

on children under 3 years of age

Section 51727-6

Inactive ingredients

colloidal silicon dioxide, corn starch, lactose, magnesium stearate, povidone, sodium starch glycolate

Section 51945-4

Fortolin

Pain Reliever Fever Reducer

NDC 51467-127-24

Aspirin Free

Contain no aspirin and are unlikely to cause gastric irritation.

Acetaminophen 500 mg

24 Tablets

Safety Sealed

Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

Section 53413-1

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm PST

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain reliever-fever reducer

Structured Label Content

Warnings and Precautions (34071-1)

Warnings Alcohol warning:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or otehr pain relievers/fever reducers.

Acetaminophen may cause liver damage

Active Ingredient (55106-9)

Active ingredients

Acetaminophen 500 mg

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains associated with the common cold

headache

toothache

muscular aches

To reduce fever

Dosage and Administration (34068-7)

Directions

Take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years of age : consult a docto

Section 44425-7 (44425-7)

Other information

Each tablet contains sodium 0.496 mg

Keep tightly closed

Store in original packaging, away from sunlight

Section 50565-1 (50565-1)

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 children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

you need to use this product for pain for mroe than 10 days

fever lasts for more than 3 days (72 hours) or ets worse

new symptoms occur

redness or swelling is present (these could be signs of a serious condition)

Section 50570-1 (50570-1)

Do not use

on children under 3 years of age

Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, corn starch, lactose, magnesium stearate, povidone, sodium starch glycolate

Section 51945-4 (51945-4)

Fortolin

Pain Reliever Fever Reducer

NDC 51467-127-24

Aspirin Free

Contain no aspirin and are unlikely to cause gastric irritation.

Acetaminophen 500 mg

24 Tablets

Safety Sealed

Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.

Section 53413-1 (53413-1)

Questions or comments?

(888) 221-3496 M-F 9 am to 5 pm PST

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain reliever-fever reducer

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For the temporary relief of minor aches and pains associated with the common cold headache toothache muscular aches To reduce fever", "34068-7": "Directions Take 1 tablet every 3 to 4 hours or 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years of age : consult a docto", "34071-1": "Warnings Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or otehr pain relievers/fever reducers. Acetaminophen may cause liver damage", "44425-7": "Other information Each tablet contains sodium 0.496 mg Keep tightly closed Store in original packaging, away from sunlight", "50565-1": "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 children even if you do not notice any signs or symptoms.", "50566-9": "Stop use and ask a doctor if you need to use this product for pain for mroe than 10 days fever lasts for more than 3 days (72 hours) or ets worse new symptoms occur redness or swelling is present (these could be signs of a serious condition)", "50570-1": "Do not use on children under 3 years of age", "51727-6": "Inactive ingredients colloidal silicon dioxide, corn starch, lactose, magnesium stearate, povidone, sodium starch glycolate", "51945-4": "Fortolin Pain Reliever Fever Reducer NDC 51467-127-24 Aspirin Free Contain no aspirin and are unlikely to cause gastric irritation. Acetaminophen 500 mg 24 Tablets Safety Sealed Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened.", "53413-1": "Questions or comments? (888) 221-3496 M-F 9 am to 5 pm PST", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain reliever-fever reducer", "55106-9": "Active ingredients Acetaminophen 500 mg"}