ZEE ASPIRIN- aspirin tablet 
Zee Medical Inc

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.

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Drug Facts

Active Ingredient/Tablet Aspirin 325 mg

Purpose-Pain Reliever/Fever Reducer

Temporarily relieves pain due 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, 

MM Aspirin, 250 Box

second box label1

ZEE ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND (FR21) Size10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-232-6850 in 1 CARTON06/12/201202/01/2023
1NDC:35418-232-67125 in 1 CARTON
1NDC:35418-232-022 in 1 PACKET; Type 0: Not a Combination Product
2NDC:35418-232-7024 in 1 BOX06/12/201202/01/2023
2NDC:35418-232-67125 in 1 CARTON
2NDC:35418-232-022 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/12/201202/01/2023
Labeler - Zee Medical Inc (009645623)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-232)

Revised: 1/2023
 
Zee Medical Inc