ZEE UNASPIRIN ES- acetaminophen tablet

Zee Unaspirin by

Drug Labeling and Warnings

Zee Unaspirin by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient/TabletAcetaminophen 500mg

PURPOSE

Purpose-Pain Reliever/Fever Reducer

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

Children under 12 years, ask a doctor

WARNINGS

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

Inactive Ingredients: corn starch, microcrystalline cellulose,  
povidone,  sodium starch glycolate, and stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZEE UNASPIRIN  ES
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (FR1)	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-210-69	500 in 1 CARTON	06/12/2012
1	NDC: 35418-210-68	50 in 1 CARTON
1	NDC: 35418-210-67	125 in 1 CARTON
1	NDC: 35418-210-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Zee Medical Inc (009645623)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(35418-210)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(35418-210)