PAIN STOPPERS- acetaminophen, caffeine, aspirin, salicylamide tablet 
PAIN STOPPERS REGULAR- acetaminophen, caffeine, aspirin, salicylamide tablet 
Honeywell Safety Products USA, Inc

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.

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0498-2422 & 0498-2421: Pain Stoppers

Active ingredients (in each tablet)

Acetaminophen 110mg

Aspirin 162mg (NSAID)*

Caffeine 32.4mg

Salicylamide 152mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Pain reliever/fever reducer

Diuretic

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:

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

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

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.

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.

Keep out of reach of children.

Overdose warning: 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.

Directions

Other Information

Inactive Ingredients

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

Questions or comments?

1-800-430-5490

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PAIN STOPPERS 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2422
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colororange (BRIGHT ORANGE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2422-50500 in 1 BOX01/02/2017
1NDC:0498-2422-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0498-2422-25250 in 1 BOX01/02/2017
2NDC:0498-2422-012 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0498-2422-10100 in 1 BOX01/02/2017
3NDC:0498-2422-012 in 1 PACKET; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE K30 (UNII: U725QWY32X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Colororange (BRIGHT ORANGE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2421-50250 in 1 CARTON04/18/201301/01/2017
1NDC:0498-2421-25125 in 1 CARTON
1NDC:0498-2421-1050 in 1 CARTON
1NDC:0498-2421-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/18/201301/01/2017
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.812503712repack(0498-2421, 0498-2422) , relabel(0498-2421, 0498-2422)

Revised: 12/2021
Document Id: d2a95f01-9e3f-dcb7-e053-2995a90a925b
Set id: 49b1e49f-e09e-4db5-9230-bf69b6881f82
Version: 14
Effective Time: 20211208
 
Honeywell Safety Products USA, Inc