Medication Guide App

Pain Stopper Extra

Dosage form: tablet
Ingredients: ACETAMINOPHEN 110mg, ASPIRIN 162mg, CAFFEINE 32.4mg, SALICYLAMIDE 152mg
Labeler: North Safety Products LLC
NDC Code: 0498-2420

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.

DRUG FACTS

Active Ingredients (In Each Tablet)                        
Acetaminophen 110 mg
Aspirin 162 mg
Salicylamide 152 mg
caffeine 32.4 mg

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Pain reliever/Fever reducer

Uses: temporarily relieves minor aches and pains associated with:
•    backache
•    headaches
•    colds
•    toothache
•    minor arthritis pain 
•    muscular aches
•    menstrual cramps 

Directions:
•    Adults and children 12 years of age and older.    2 tablets as needed for pain every 4 hours.  Do not exceed 8 tablets in 24 hours or as directed by a doctor

•    Children under 12 years    Consult 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-Do not use:
•    if you are allergic to aspirin or any other salicylate
•    if you have ever had an allergic reaction to any other pain 
reliever/fever reducer 
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
Do not use:
•    with 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
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

        When using this product do not exceed recommended dose
 
      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. 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. 

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:  FDC Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Starch, Stearic Acid,

MM1

PAIN STOPPER EXTRA 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2420
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN110 mg
ASPIRIN (ASPIRIN) ASPIRIN162 mg
CAFFEINE (CAFFEINE) CAFFEINE32.4 mg
SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE152 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
POVIDONE K30 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
FD&C YELLOW NO. 6 
Product Characteristics
Colororange (BRIGHT ORANGE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeFR;2
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-2420-50250 CARTON (PACKET) in 1 CARTON
1NDC:0498-2420-25125 CARTON (PACKET) in 1 CARTON
1NDC:0498-2420-1050 PACKET (PACKET) in 1 CARTON
1NDC:0498-2420-012 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/07/2012
Labeler - North Safety Products LLC (059980441)
Registrant - North Safety Products LLC (059980441)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc. 151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 04/2012
 
North Safety Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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