Aramark Ibuprofen
FDA Label NDC 81238-0103

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 Ibuprofen (NDC 81238-0103). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts

Active Ingredient (in each tablet)
​Ibuprofen 200 mg (NSAID)*

Otc - Purpose

Purpose
Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

Indications & Usage

Uses:
Temporarily Relieves minor aches and pains
due to:
• Headache, toothaches, menstrual cramps,
  the common cold,
• muscular aches, minor pain of arthritis
  Temporarily reduces fever

Warnings

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic
reaction, especially in people allergic to aspirin.
Symptoms may include:
• hives, facial swelling, asthma (wheezing), shock,
  skin reddening, rash, blisters

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 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

Otc - Do Not Use

Do not use:
• if you have ever had an allergic reaction to any
  other pain
• reliever/fever reducer
• right before or after heart surgery
• if you have ever had an allergic reaction to this
  product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if:
• stomach bleeding warning applies to you
• you have problems or serious side effects from
  taking pain
• relievers or fever reducers
• you have a history of stomach problems, such
  as heartburn
• you have high blood pressure, heart disease, liver
  cirrhosis, kidney disease, or asthma
• you are taking a diuretic

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are:
• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because
  ibuprofen may decrease the benefit of aspirin
• taking the blood thinning drug Warfarin

Otc - When Using

When using this product:
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if
  you use more than directed or for longer than
  directed

Otc - Stop Use

Stop use and ask a doctor if:
• 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
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the
  painful area
• any new symptoms occur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health
professional before use. It is especially important
not to use ibuprofen during the last 3 months of
pregnancy unless definitely 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.

Dosage & Administration

Directions:
• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: take 1 tablet
  every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 tablet,
  2 tablets may be used
• do not exceed 6 tablets in 24 hours, unless
  directed by a doctor
• children under 12 years: ask a doctor

Other Safety Information

Other information:
read all warnings and directions before use. Keep
carton. Store at 20-25°C (68-77°F) avoid excessive
heat above 40°C (104°F)

Inactive Ingredient

Inactive Ingredients:
colloidal silicon dioxide, corn starch, sodium starch
glycollate, hypromellose, lactose monohydrate,
povidone, pregelatinized corn starch, red iron oxide,
sodium starch glycolate, steric acid, talc, titanium
dioxide, triacetin, purified water

Product Package

aramark

100 TABLETS PER BOX            Part # 552R23

Ibuprofen
Anti-Inflammatory Fever
Reducer

Compare active ingredient to:

ADVIL®
Registered Trademark of Pfizer Consumer Healthcare

Retain carton for complete product information

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

aramarkuniform.com

100 Tablet Box

250 Tablet Box

2-Tablet Packet

res

* Please review the disclaimer below.