Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID c08fdd22-2e0d-4467-bf70-54fcfef46550
Route
ORAL
Published
Effective Date 2012-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: C15 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-05-15

Description

Acetaminophen


Medication Information

Warnings and Precautions

Do not use this product if you have  had an allergic to Acetaminophen or any of the inactive ingredients. Ask a doctor before taking this product if you have Liver disease or are taking blood thinning medication. Do not take more than directed.If pregnant or breast feeding contact a doctor before using this product. Stop use and consult a doctor if: Pain gets worse or last more than 10 days: If fever gets worse or last more than 3 days: new symptoms appear: redness or swelling appear.

Indications and Usage

Oral analgesic.

Dosage and Administration

Adults and children 12 years and over: Take 2 tablets at bedtime(Do not take more than 2 tablets in a 24 hour time)

Description

Acetaminophen

Section 50565-1


Keep out of reach of children. In case of overdose, get medical help right away and contact a poison control center right away.

Section 51727-6


Povidone

pregelatinized starch

stearic acid

Section 51945-4

image of carton

Section 55105-1

Oral Analgesic

Section 55106-9

Acetaminophen


Structured Label Content

Indications and Usage (34067-9)

Oral analgesic.

Dosage and Administration (34068-7)

Adults and children 12 years and over: Take 2 tablets at bedtime(Do not take more than 2 tablets in a 24 hour time)

Warnings and Precautions (34071-1)

Do not use this product if you have  had an allergic to Acetaminophen or any of the inactive ingredients. Ask a doctor before taking this product if you have Liver disease or are taking blood thinning medication. Do not take more than directed.If pregnant or breast feeding contact a doctor before using this product. Stop use and consult a doctor if: Pain gets worse or last more than 10 days: If fever gets worse or last more than 3 days: new symptoms appear: redness or swelling appear.

Section 50565-1 (50565-1)


Keep out of reach of children. In case of overdose, get medical help right away and contact a poison control center right away.

Section 51727-6 (51727-6)


Povidone

pregelatinized starch

stearic acid

Section 51945-4 (51945-4)

image of carton

Section 55105-1 (55105-1)

Oral Analgesic

Section 55106-9 (55106-9)

Acetaminophen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)