481r-tcl-49483-481 Aspirin 81mg Delayed Release Tablets

481r-tcl-49483-481 Aspirin 81mg Delayed Release Tablets
SPL v8
SPL
SPL Set ID e839bff7-779a-446d-8486-c0e0a1b6d665
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide D&c Yellow No. 10 Ferric Oxide Yellow Methacrylic Acid And Ethyl Acrylate Copolymer Polysorbate 80 Dimethicone Sodium Lauryl Sulfate Starch, Corn Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: HEART Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-19

Description

Aspirin 81mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Aspirin 81mg (NSAID*) *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:hives, facial swelling, shock, asthma(wheezing).

Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if:

You are age 60 or older

Have had stomach bleeding problems

Take a blood thinning (anticoagulant) or steroid drug

Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

Directions

Drink a full glass of water with each dose

Adults and children of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years: consult a doctor

Inactive Ingredients

Anhydrous lactose, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Keep Out of Reach of Children

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

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Package/label Principal Display Panel

Structured Label Content

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

Purpose

Pain Reliever

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:hives, facial swelling, shock, asthma(wheezing).

Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if:

You are age 60 or older

Have had stomach bleeding problems

Take a blood thinning (anticoagulant) or steroid drug

Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

Directions

Drink a full glass of water with each dose

Adults and children of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years: consult a doctor

Inactive Ingredients

Anhydrous lactose, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Keep Out of Reach of Children

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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