Childrens Aspirin Tablet, Chewable
FDA Label NDC 55154-6752

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Childrens Aspirin (NDC 55154-6752). 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 drug facts, active ingredient (in each tablet), purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

HOSPAK® UNIT DOSE PRODUCTS

LOW STRENGTH ASPIRIN (NSAID)

81 mg

ORANGE FLAVORED, CHEWABLE TABLETS

500 COUNT UNIT DOSE TABLETS (50 - 2 x 5 strips)

FOR INSTITUTIONAL USE ONLY

Active Ingredient (In Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

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

to reduce fever

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 doctor.

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 take a diuretic -you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for ·gout ·diabetes ·arthritis

Stop use and ask a doctor 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 for more than 10 days ·redness or swelling is present ·new symptoms occur ·ringing in the ears or loss of hearing occurs ·You may report side effects to 1-888-952-0050.

If pregnant or breast-feeding, 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.

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 doctor ·children under 12 years: consult a doctor

Inactive Ingredients

dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

Storage

Store at room temperature. Do not use if packet is torn, cut or opened.

Questions? 1-815-877-6480

Mfg. by: Allegiant Health, Deer Park, NY 11729

Dist. By: Hospak® Unit Dose Products, Rockford, IL 61114

Hospak is a trademark owned by its respective owner.

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L40737140815

Rev. 03/15

Principal Display Panel

Children's Aspirin (NSAID) 81 MG

10 Flavored Chewable Tablets

* Please review the disclaimer below.