PAIN AID BRF- acetaminophen magnesium salicylate tablet

Pain Aid BRF by

Drug Labeling and Warnings

Pain Aid BRF by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultra Seal Corporation , Ultratab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Pain Reliever

INDICATIONS & USAGE

Temporarily relieves minor back pain

DOSAGE & ADMINISTRATION

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

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:

• 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

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

PREGNANCY OR BREAST FEEDING

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

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, DC Yellow 10, FDC Yellow 6, microcrystalline cellulose,  polydextrose, povidone, propylene glycol, silicon dioxide, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

PAIN AID BRF 
acetaminophen magnesium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (light orange)	Score	no score
Shape	ROUND (FR40)	Size	12mm
Flavor		Imprint Code	FR40
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-801-68	50 in 1 CARTON	08/19/2012
1	NDC: 35418-801-67	125 in 1 CARTON
1	NDC: 35418-801-02	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	08/19/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(35418-801)