Pain Aid BRF description, usages, side effects, indications, overdosage, supplying and lots more!

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Pain Aid BRF

Zee Medical Inc
Ultra Seal Corporation

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose-Pain Reliever

Uses

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
















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

MM1Pain Aid BRF

Pain Aid BRF

Acetaminophen Magnesium Salicylate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35418-801
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Magnesium Salicylate SALICYLIC ACID 250 mg
ACETAMINOPHEN ACETAMINOPHEN 250 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
orange (light orange) 12 mm FR40 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:35418-801-02 2 in 1 PACKET
2 NDC:35418-801-67 125 in 1 CARTON
3 NDC:35418-801-68 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-08-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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