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Zee Unaspirin ES

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Zee Medical Inc
NDC Code: 35418-210

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/TabletAcetaminophen 500mg

Purpose-Pain Reliever/Fever Reducer

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

Adults: Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

Children under 12 years, ask a doctor


Liver Warning: This product contains acetaminophen. Severe liver damage
     may occur if you take:
•    more than 8 tablets in 24 hours
•    with other drugs containing acetaminophen (prescription or nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure.  
•    3 or more alcoholic drinks every day while using this product
______________________________________________________________
Do not use:
•    with any other product containing acetaminophen this will provide more  
than the recommended dose (overdose) of acetaminophen and could  
cause serious health concerns.  
•    for more than 10 days for pain unless directed by a doctor
•    for more than 3 days for fever unless directed by a doctor
•    When using this product do not exceed recommended dose.
_______________________________________________________________
Stop use and ask a doctor if:
•    symptoms do not improve
•    pain or fever persists or gets worse
•    new symptoms occur
•    redness or swelling is present

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,  sodium starch glycolate, and stearic acid

Mm1

ZEE UNASPIRIN  ES
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND (FR1) Size12mm
FlavorImprint CodeFR1
Contains    
Packaging
#Item CodePackage Description
1NDC:35418-210-69500 CARTON (PACKET) in 1 CARTON
1NDC:35418-210-6850 CARTON (PACKET) in 1 CARTON
1NDC:35418-210-67125 PACKET (PACKET) in 1 CARTON
1NDC:35418-210-022 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 - Zee Medical Inc (009645623)
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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