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 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.

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.
Ask a doctor or pharmacist before use if you are
• taking any other drug containing an NSAID
(prescription or nonprescription) • taking a blood
thinning (anticoagulant) or steroid drug • taking a
prescription drug for diabetes, gout or arthritis

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.

If pregnant or breast-feeding, ask a health
professional before use. It is especially important not to
use aspirin 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.

image of cartonEnter section text here

HALFPRIN  LOW DOSE ASPIRIN
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-172
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 
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
CELLULOSE, MICROCRYSTALLINE 
Mineral Oil 
POLYETHYLENE GLYCOL 1000 
Polysorbate 80 
Titanium Dioxide  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code embossed;upper;heart;lower;plain
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-172-18180 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/24/201010/08/2013
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Time Caps Labs037052099manufacture(55505-172)

Revised: 10/2013
 
Kramer Laboratories