PAIN STOPPERS- acetaminophen, caffeine, aspirin, salicylamide tablet 
PAIN STOPPERS REGULAR- acetaminophen, caffeine, aspirin, salicylamide tablet 
North Safety Products LLC

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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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:

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

Ask a doctor before use if

Stop using and ask a doctor if

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

Other Information

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

NORTH Regular Pain 100 carton

Pain Stoppers 100CT

Pain stoppers 100CT

Pain Stoppers 250CT

Pain Stoppers 250CT

Pain Stoppers 500CT

Pain Stoppers 500CT

PAIN STOPPERS 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2422
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg
Inactive Ingredients
Ingredient Name Strength
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
Color orange (BRIGHT ORANGE) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code FR;2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-2422-50 500 in 1 BOX 01/02/2017
1 NDC:0498-2422-01 2 in 1 PACKET; Type 0: Not a Combination Product
2 NDC:0498-2422-25 250 in 1 BOX 01/02/2017
2 NDC:0498-2422-01 2 in 1 PACKET; Type 0: Not a Combination Product
3 NDC:0498-2422-10 100 in 1 BOX 01/02/2017
3 NDC:0498-2422-01 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 01/02/2017
PAIN STOPPERS REGULAR 
acetaminophen, caffeine, aspirin, salicylamide tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-2421
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 110 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 162 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.4 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE 152 mg
Inactive Ingredients
Ingredient Name Strength
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
Color orange (BRIGHT ORANGE) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code FR;2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-2421-50 250 in 1 CARTON 04/18/2013 01/01/2017
1 NDC:0498-2421-25 125 in 1 CARTON
1 NDC:0498-2421-10 50 in 1 CARTON
1 NDC:0498-2421-01 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 04/18/2013 01/01/2017
Labeler - North Safety Products LLC (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
Name Address ID/FEI Business Operations
North Safety Products LLC 019777263 repack(0498-2421, 0498-2422)
Establishment
Name Address ID/FEI Business Operations
Ultra Seal Corporation 085752004 pack(0498-2421, 0498-2422)
Establishment
Name Address ID/FEI Business Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture(0498-2421, 0498-2422)

Revised: 12/2017
Document Id: 60b6b7a7-2e93-a6da-e053-2a91aa0a792e
Set id: 49b1e49f-e09e-4db5-9230-bf69b6881f82
Version: 9
Effective Time: 20171219
 
North Safety Products LLC