Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID de3e223f-8d22-4034-b049-983b4a60daf5
Route
ORAL
Published
Effective Date 2014-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Cellulose, Microcrystalline Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Stearic Acid Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: C3 Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-10-01

Description

ASPIRIN


Medication Information

Warnings and Precautions

Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Children or teenagers who are recovering from the Chicken Pox or flu like symptoms should not use this product. When using this product if changes in behavior occur with nausea and vomiting occur,consult a Doctor because this could be a sign of Reye's Syndrome, a rare

 but serious illness.

Indications and Usage

For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.

Dosage and Administration

Directions - drink a full glass of water with each dose. Adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor

Description

ASPIRIN

Section 50565-1

In case of over dose get medical help and contact a Poison Control Center immediately.

Section 51727-6

Inactive Ingredients

Section 51945-4

Section 55105-1

Purpose

Pain Reliever

Section 55106-9

ASPIRIN


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.

Dosage and Administration (34068-7)

Directions - drink a full glass of water with each dose. Adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor

Warnings and Precautions (34071-1)

Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Children or teenagers who are recovering from the Chicken Pox or flu like symptoms should not use this product. When using this product if changes in behavior occur with nausea and vomiting occur,consult a Doctor because this could be a sign of Reye's Syndrome, a rare

 but serious illness.

Section 50565-1 (50565-1)

In case of over dose get medical help and contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Pain Reliever

Section 55106-9 (55106-9)

ASPIRIN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)