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Pain Stoppers

Dosage form: tablet
Ingredients: ACETAMINOPHEN 110mg, ASPIRIN 162mg, CAFFEINE 32.4mg, SALICYLAMIDE 152mg
Labeler: North Safety Products LLC
NDC Code: 0498-2422

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.

Pain Stoppers

Active ingredients

In each tablet:

Acetaminophen 110mg

Aspirin 162mg

Caffeine 32.4mg

Salicylamide 152mg

Purpose

Pain reliever, fever reducer

Uses

for the temporary relief of minor aches and pains due to:

• common cold

• headache

• muscular aches

• premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 12 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

Stop using and ask a doctor if
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pin that does not get better
  • if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

If pregnant or breast feeding

If pregnant or breast feeding, ask a healthcare professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during pregnancy.

Directions
  • adults and children 12 years of age and over, take 2 tablets every 4 hours while symptoms persist
  • do not take more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information
  • store at a controlled room temperature 15 o-30 oC (59 o-86 oF)
  • do not use if package is opened or torn

Inactive Ingredients

FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,

Questions or comments?

1-800-430-5490

Pain Stoppers regular

MM1

Pain Stoppers 100CT

Pain Stoppers 250CT

Pain Stoppers 500CT

PAIN STOPPERS 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2422
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:0498-2422-50500 PACKET in 1 BOX
1NDC:0498-2422-012 TABLET in 1 PACKET
2NDC:0498-2422-25250 PACKET in 1 BOX
2NDC:0498-2422-012 TABLET in 1 PACKET
3NDC:0498-2422-10100 PACKET in 1 BOX
3NDC:0498-2422-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
PAIN STOPPERS REGULAR 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2421
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:0498-2421-50250 CARTON in 1 CARTON
1NDC:0498-2421-25125 CARTON in 1 CARTON
1NDC:0498-2421-1050 PACKET in 1 CARTON
1NDC:0498-2421-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/18/201301/01/2017
Labeler - North Safety Products LLC (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products LLC019777263repack(0498-2421, 0498-2422)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004pack(0498-2421, 0498-2422)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(0498-2421, 0498-2422)

Revised: 12/2017
 
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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