HALFPRIN LOW DOSE- aspirin tablet, coated 
Kramer Laboratories

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.

----------

Aspirin 162 mg

Pain reliever

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

For the temporary relief of minor aches and
pains or as recommended by your doctor. If
immediate relief is needed, chew the tablet
for quicker absorption.

Directions: drink a full glass of water with each dose; adults and children 12 years and over: take 2 to 4 tablets every 4 hours not to exceed 24 tablets in 24 hours unless directed by a doctor
Children under 12 years - consult a doctor

Corn Starch, croscarmellose Sodium, DandC yellow no.10, FDandC RED NO. 40 ,FDandC YELLOW NO. 6,Hypromellose,HYPROMELLOSE
PHTHALATE ,CELLULOSE, MICROCRYSTALLINE  ,Mineral Oil ,Polysorbate 80, POLYETHYLENE GLYCOL , Titanium Dioxide

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.


image of pouchEnter section text here

HALFPRIN  LOW DOSE
asprin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN162 mg  in 162 
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
croscarmellose sodium 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
CELLULOSE, MICROCRYSTALLINE 
Mineral Oil 
POLYETHYLENE GLYCOL 
Polysorbate 80 
Titanium Dioxide  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code embossed;upper;heart;lower;plain
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-136-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/02/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Time Caps Labs037052099manufacture

Revised: 12/2010
 
Kramer Laboratories