Chewable Aspirin Tablet, Chewable
FDA Label NDC 85828-288

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grocery Outlet for the product Chewable Aspirin (NDC 85828-288). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If

→ Stop Use And Ask A Doctor before Use If

→ If Pregnant Or Breastfeeding,

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions/comments

→ Principal Display Panel

Active Ingredient(S)

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

Purpose

Pain reliever

Use(S)

temporary relief of minor aches and pains or as recommended by your doctor

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, asthma (wheezing), shock.

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 ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed

Do Not Use

if you are allergic to aspirin or any other pain reliever/fever reducer
this product for at least 7 days after tonsillectomy or oral surgery unless directed by
a doctor
if you have ever had an allergic reaction to this product or any of its
ingredients

Ask A Doctor Before Use If

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma

Ask A Doctor Or Pharmacist Before Use If

taking a prescription drug for

gout
diabetes
arthritis

Stop Use And Ask A Doctor Before Use If

an allergic reaction occurs. Seek medical help right away
you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
pain gets worse or lasts more than 10 days
redness or swelling is present
new symptoms occur
ringing in the ears or loss of hearing occurs

If Pregnant Or Breastfeeding,

ask a health professional before use. It is especially
important not to use aspirin during the last 3 months of pregnancy unless
specifically directed to do so by a doctor because it may cause problems in the
unborn child or complications during delivery.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 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