Aramark Aspirin
FDA Label NDC 81238-0232

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Western First Aid Safety Dba Aramark for the product Aramark Aspirin (NDC 81238-0232). 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, otc - purpose, indications & usage, warnings, other, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

(in Each Tablet)

Aspirin USP (NSAID)*  325 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose
Pain Reliever/Fever Reducer

Indications & Usage

Uses: temporarily relieves minor pain
due to: • headache • menstrual pain
• minor pain of arthritis • muscle pain
• pain and fever of colds • toothache
• temporarily reduces fever

Warnings

Warnings:
Reye’s Syndrome: • Children and teenagers
should not use this medicine for chicken pox or
flu symptoms before a doctor is consulted about
Reye’s Syndrome, a rare but serious illness
reported to be associated with aspirin

Other

Allergy Alert - Do not use:
• if you are allergic to aspirin or any other
  salicylate
• if you have ever had an allergic reaction to any
  other pain reliever/fever reducer

Stomach Bleeding Warning:
This product contains nonsteroidal
anti-inflammatory drugs (NSAIDs), which may
cause 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 an NSAID
  (aspirin, ibuprofen, naproxen, or others)
• take more or for a longer time than directed

Do not use:
• with any other pain reliever/fever reducer

Ask doctor before using if you have:
• upset stomach or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older

Ask a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID
  (prescription or nonprescription) taking a blood
  thinning (anticoagulant) or steroid drug

Stop use and ask a doctor if: ringing in the
ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or
  black stools. These are signs of stomach
  bleeding.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, 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.

Otc - 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.
Prompt medical attention is critical for adults as
well as children even if you do not notice any
signs or symptoms.

Dosage & Administration

Directions:
• Adults and children
  12 years of age and
  older:

Take 2 tablets every 4
to 6 hours as needed.
Do not exceed 12 tablets
in 24 hours or as directed
by a doctor.

 • Children under
   12 years:
Consult a doctor.

Inactive Ingredient

Inactive Ingredients: FD&C Yellow #6,
Magnesium Stearate, Microcrystalline
Cellulose, Povidone, Starch, Stearic Acid

Product Package

aramark

Aspirin

Part # 556R23

100 TABLETS PER BOX

Compare active ingredient to:
BAYER®
Registered Trademark of Bayer Corp.

Retain carton for complete product information

MANUFACTURED FOR:
Aramark
Lenexa, KS 66219
(913) 269-9611

Box

Packet

res

* Please review the disclaimer below.