FDA Label for Aramark Ibuprofen

View Indications, Usage & Precautions

Aramark Ibuprofen Product Label

The following document was submitted to the FDA by the labeler of this product Western First Aid Safety Dba Aramark. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.