Aspirin by Kareway Product, Inc. ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each tablet)

Aspirin 325mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

• headache
• muscle pain
• toothache
• menstrual pain
• minor pain of arthritis
• pain and fever of colds
  

Warnings

Reye's syndrome:Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert:Aspirin may cause a severe allergic reaction which may include:

• hives
• shock
• facial swelling
• asthma (wheezing)
  

Alcohol warning:

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain reliever/fever reducers. Aspirin may cause stomach bleeding.

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if you have

• stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
• bleeding problems
• ulcers
• asthma
  

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• anticoagulation (blood thinning)
• gout
• diabetes
• arthritis
  

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• new symptoms occur
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• fever lasts more than 3 days
• 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 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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: consult a doctor
  

Other information

• save carton for full directions and warnings
• store at room temperature
  

Inactive ingredients

dry starch, citric acid, carboxymethyl starch sodium, starch, starch paste

PRINCIPAL DISPLAY PANEL

Aspirin

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0008-1	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	11/23/2011

Labeler - Kareway Product, Inc. (121840057)