HALFPRIN LOW DOSE ASPIRIN - aspirin  tablet, coated 
Kramer Laboratories

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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

Inactive ingredients: Acetylated Monoglycerides, Corn Starch, Croscarmellose
Sodium, DC Yellow 10 Aluminum Lake, FDC Red 40 Aluminum Lake, FDC
Yellow 6 Aluminum Lake, Hypromellose, Hypromellose Phthalate, Microcrystalline
Cellulose, Mineral Oil, Polyethylene Glycol (PEG)-400, Polysorbate 80, Titanium

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.

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HALFPRIN  LOW DOSE ASPIRIN aspirin   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55505-102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aspirin (aspirin ) aspirin 162 mg  in 162

Inactive Ingredients Ingredient Name Strength 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   Polysorbate 80   Titanium Dioxide

Product Characteristics Color red Score no score Shape ROUND Size 8mm Flavor Imprint Code embossed;upper;heart;lower;plain Contains

Packaging # NDC Package Description Multilevel Packaging 1 55505-102-13 60 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/02/2010

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Operations
Time Caps Labs		037052099	manufacture

Revised: 12/2010Kramer Laboratories