Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f572d9fe-035b-4c23-93a2-c7672261066e
Route
ORAL
Published
Effective Date 2012-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Yellow No. 6 Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Cellulose, Microcrystalline Stearic Acid 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 2012-05-15

Description

Aspirin


Medication Information

Warnings and Precautions


Do not use this product if you are allergic to Aspirin or any other pain/fever product.

If pregnant or breastfeeding contact a doctor before using.

Contact a doctor or pharmacist if you are taking a prescription drug for-Gout, Diabetes or Arthritis.

Contact a doctor right away if: An allergic reaction occurs.

Indications and Usage
Oral Analgesic. Aspirin is not appropriate for everyone, so be sure to talk to a doctor before starting an Aspirin regimen.

Dosage and Administration


Drink a full glass of water with each dose.

Adults and children 12 years of age and up:Take 4-8 tablets every 4 hours not to exceed 48 tablets in 24hours unless indicated by a doctor.. Children under 12 years of age : Consult a Doctor.

Description

Aspirin

Section 50565-1

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

Section 51727-6

Yellow # 10

Yellow # 6

Methacrylic Acid Copolymer

Microcrystalline Cellose

Stearic Acid

Titanium Dioxide

Triethyl Citrate

Section 51945-4

Image of carton

Section 55105-1
Internal Analgesic.

Section 55106-9


Aspirin


Structured Label Content

Indications and Usage (34067-9)
Oral Analgesic. Aspirin is not appropriate for everyone, so be sure to talk to a doctor before starting an Aspirin regimen.

Dosage and Administration (34068-7)


Drink a full glass of water with each dose.

Adults and children 12 years of age and up:Take 4-8 tablets every 4 hours not to exceed 48 tablets in 24hours unless indicated by a doctor.. Children under 12 years of age : Consult a Doctor.

Warnings and Precautions (34071-1)


Do not use this product if you are allergic to Aspirin or any other pain/fever product.

If pregnant or breastfeeding contact a doctor before using.

Contact a doctor or pharmacist if you are taking a prescription drug for-Gout, Diabetes or Arthritis.

Contact a doctor right away if: An allergic reaction occurs.

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.

Section 51727-6 (51727-6)

Yellow # 10

Yellow # 6

Methacrylic Acid Copolymer

Microcrystalline Cellose

Stearic Acid

Titanium Dioxide

Triethyl Citrate

Section 51945-4 (51945-4)

Image of carton

Section 55105-1 (55105-1)
Internal Analgesic.

Section 55106-9 (55106-9)


Aspirin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)