ASPIRIN- aspirin tablet, coated 
Liberty Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASPIRIN FOR TIME CAP

Each tablet contains Aspirin 325 mg

corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

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
You have not been drinking fluids
You have lost a lot of fluid due to vomiting or diarrhea



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, shock, asthma (wheezing)

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

Directions: 

Drink a full glass of water with each dose

Adults and children 12 years and over:  take 1 to 2 tablets every 4 hours while symptoms last

Do not take more than 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years: consult a doctor

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

Pain Reliever

Uses:

For the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor.

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

IMAGE LABEL 

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0440-1130(NDC:49483-011)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 ng
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0440-1130-9090 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/18/2012
Labeler - Liberty Pharmaceuticals, Inc. (012568840)

Revised: 9/2013
Document Id: c2183561-837b-447a-8f41-8d9ac3457188
Set id: 2d368df5-c176-435d-b8b9-a171f972fd14
Version: 1
Effective Time: 20130905
 
Liberty Pharmaceuticals, Inc.