Your browser does not support JavaScript! PAIN AID BRF (ACETAMINOPHEN MAGNESIUM SALICYLATE) TABLET [ZEE MEDICAL INC]
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PAIN AID BRF (acetaminophen magnesium salicylate) tablet
[Zee Medical Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredient/TabletAcetaminophen 250mg, Magnesium Salicylate Tetrahydrate 250 mg (NSAID)

Purpose-Pain Reliever

Temporarily relieves minor back pain

Adults: Take 2 tablets every 6 hours, not more than 8 tablets in 24 hours

Children under 12 years, ask a doctor


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: Magnesium Salicylate may cause a severe allergic reaction which may include: Hives, facial swelling, asthma (wheezing), shock

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
Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause stomach bleeding.  The chance is higher if you:
o    are age 60 or older
o    have had stomach ulcers or bleeding problems
o    take a blood thinning (anticoagulant) or steroid drug
o    take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others.
o    Take more or for a longer time than directed

Ask a doctor before use if : Stomach bleeding warnings apply to you, you have a history of stomach problems such as heartburn, you have asthma, high blood pressure, heart disease, liver disease or kidney disease______________________________________________________________
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.
_Do not use:
•    if you are allergic to aspirin or salicylates
•    with any other pain reliever/fever reducer
•    if you have ever had an allergic reaction to any other pain 
reliever/fever reducer 
•    for pain for more than 10 days or for fever for more than 3 
days unless directed by a doctor
•    with any other product containing acetaminophen
______________________________________________________________
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

Ask a doctor or pharmacist before use if you are taking a prescription drug for:
•    anticoagulation (thinning of blood)
•    diabetes
•    gout
•    arthritis

Stop use and ask a doctor if:
           An allergic reaction occurs.  Seek medical help right away.
           You experience any of the following signs of stomach bleeding:
           feel faint, vomit blood, have black or bloody stools, have stomach pain that does not get better
•    ringing in the ears or loss of hearing occurs
•    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. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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.  
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, DC Yellow 10, FDC Yellow 6, microcrystalline cellulose,  polydextrose, povidone, propylene glycol, silicon dioxide, stearic acid, titanium dioxide

MM1BRF, 250 Box

PAIN AID BRF 
acetaminophen magnesium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SALICYLATE (SALICYLIC ACID) MAGNESIUM SALICYLATE250 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
STEARIC ACID 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 300 
POVIDONE 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
Colororange (light orange) Scoreno score
ShapeROUND (FR40) Size12mm
FlavorImprint Code FR40
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-801-6850 in 1 CARTON
1NDC:35418-801-67125 in 1 CARTON
1NDC:35418-801-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/19/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-801)

Revised: 7/2012
 
Zee Medical Inc

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