Zee Aspirin

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Zee Medical Inc
NDC Code: 35418-232

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.

Drug Facts

Active Ingredient/Tablet Aspirin 325 mg

Purpose-Pain Reliever/Fever Reducer

Temporarily relieves pain dut to: headache, muscular aches, cold, minor pain of arthritis.  Temporarily reduces fever

Adults: Take 2 tablets every 4hours, not to exceed 12 caplets in 24 hours

Children under 12 years, ask a doctor


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.

 Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others.
•    Take more or for a longer time than directed
Allergy Alert-Do not use:
•    if you are allergic to aspirin or any other salicylates
•    If you have ever had an allergic reaction to any other pain 
reliever/fever reducer 
Do not use:
•    with any other pain reliever/fever reducer
Ask doctor before using if you have:
•    upset stomach or stomach pain
•    ulcers
•    bleeding problems
•    high blood pressure
•    heart or kidney disease
•    taken a diuretic
•    reached age 60 or older
      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

________________________________
   
      Stop use and ask a doctor if:
•    ringing in the ears or loss of hearing occurs
•    pain or fever persists or gets worse
•    new symptoms occur
•    redness or swelling is present
•    you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding

If pregnant or breast-feeding baby, ask a health professional  
before use

KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
get medical help or contact a Poison Control Center right away.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive Ingredients: corn starch, microcrystalline cellulose,  
povidone, 

MM1

ZEE ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-232
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
POVIDONE K29/32 
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND ( FR21) Size10mm
FlavorImprint CodeFR21
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-232-6850 CARTON (PACKET) in 1 CARTON
1NDC:35418-232-67125 PACKET (PACKET) in 1 CARTON
1NDC:35418-232-022 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIOperations
Ultratab Laboratories, Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 06/2012
 
Zee Medical Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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