Your browser does not support JavaScript! PAIN STOPPERS EXTRA (ACETAMINOPHEN, CAFFEINE, ASPIRIN) TABLET, COATED [NORTH SAFETY PRODUCTS LLC]
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PAIN STOPPERS EXTRA (acetaminophen, caffeine, aspirin) tablet, coated
[North Safety Products LLC]


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 Ingredients (In Each Tablet)                        

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Enter section text here.

Pain reliever/Fever reducer

for the temporary relief of minor aches and pain with a headache


Do not take more than directed

the smallest effective dose should be used

adults and children 12 years of age and over; take 2 tablets with a full glass of water every 4 hours

do not take more than 16 tablets in 24 hours

do not take longer than 10 days, unless directed by a doctor

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-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 directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a

cup of coffee.

When using this product:

limit the use of caffeine containing medications, food or beverages, too much caffeine may cause nervousness,sleeplessness,irritability,occasionally, rapid heartbeat

Do not use:

If you ever had an allergic reaction to any other pain reliever/fever reducer

•    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  If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist

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

      with any other drug containing an NSAID (prescription or nonprescription). Ask a doctor before using

with other drugs if you are not sure

•    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:  maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium

starch glycolate, starch, stearic acid, titanium dioxide

MM1

NORTH Extra strength Pain 250 Carton

PAIN STOPPERS EXTRA 
acetaminophen, caffeine, aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0498-2520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE65 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
POVIDONE K30 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2520-50250 in 1 CARTON
1NDC:0498-2520-25125 in 1 CARTON
1NDC:0498-2520-1050 in 1 CARTON
1NDC:0498-2520-012 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 (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(0498-2520)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(0498-2520)

Revised: 4/2013
 
North Safety Products LLC

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