HALFPRIN LOW DOSE ASPIRIN- 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.

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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 soduim, DC Yellow#10 Aluminum lake, FDC Red#40 Aluminum Lake, FDC Yellow #6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate,  simethicone,sodium hydroxide, sodium laural sulfate, talc, titanium dioxide, triethyl citrate.


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.

image of cartonEnter section text here

HALFPRIN  LOW DOSE ASPIRIN
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
aspirin (aspirin ) aspirin 162 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 
METHACRYLIC ACID 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
Polysorbate 80 
Titanium Dioxide  
DIMETHICONE  
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TRIETHYL CITRATE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code embossed;upper;heart;lower;plain
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-102-1360 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/31/201104/01/2013
Labeler - Kramer Laboratories (122720675)

Revised: 08/2011
 
Kramer Laboratories