DrugCite

LOW DOSE ASPIRIN  - aspirin tablet, chewable 
Pharbest Pharmaceuticals, Inc.

Drug Facts

Active Ingredient (in each tablet):

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains or as recommended by your doctor. 
  • ask your doctor about other uses for this product.

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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
  • asthma (wheezing)
  • facial swelling
  • 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
  • this product for at least 7 days after tonsilectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

  • the 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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture

Inactive ingredients

Corn starch, dextrose monohydrate, FD&C yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid

Questions?

Adverse drug event call: (866) 562-2756

Image of Label

LOW DOSE ASPIRIN 
aspirin  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 16103-366
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE  
SILICON DIOXIDE  
SACCHARIN SODIUM  
FD&C YELLOW NO. 6  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color orange Score no score
Shape ROUND Size 8mm
Flavor Imprint Code PH034
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16103-366-05 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 36 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (16103-366-05)
2 16103-366-11 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 08/22/2007

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
Name Address ID/FEI Operations
Pharbest Pharmaceuticals, Inc. 557054835 manufacture, pack, label
Revised: 04/2013Pharbest Pharmaceuticals, Inc.