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Pain Stoppers EX

Medically reviewed on December 20, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, CAFFEINE 65mg, ASPIRIN 250mg
Labeler: North Safety Products LLC
NDC Code: 0498-2521

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 EX

Active Ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Purpose

Pain reliever/Fever reducer

Uses

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

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 sigh 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 a 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 16 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 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

Caffeine 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
  • 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 use and ask a doctor if
  • 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 pain 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 health care 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 delivery.

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 for children even if you do not notice any signs or symptoms.

Directions
  • 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

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

Inactive Ingredients

maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium

starch glycolate, starch, stearic acid, titanium dioxide

Questions or Comments?

1-800-430-5490

Pain Stoppers EX 500CT Label

Pain Stoppers EX 100CT

Pain Soppers EX 250CT

Pain Stoppers Extra

PAIN STOPPERS EX 
acetaminophen, caffeine, aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2521
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE K30 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeFR;9
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-2521-10100 PACKET in 1 BOX
1NDC:0498-2521-012 TABLET, COATED in 1 PACKET
2NDC:0498-2521-25250 PACKET in 1 BOX
2NDC:0498-2521-012 TABLET, COATED in 1 PACKET
3NDC:0498-2521-50500 PACKET in 1 BOX
3NDC:0498-2521-012 TABLET, COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
PAIN STOPPERS EXTRA 
acetaminophen, caffeine, aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeFR;9
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-2520-50250 CARTON in 1 CARTON
1NDC:0498-2520-25125 CARTON in 1 CARTON
1NDC:0498-2520-1050 PACKET in 1 CARTON
1NDC:0498-2520-012 TABLET, COATED in 1 PACKET
2NDC:0498-2520-23100 PACKET in 1 BOX
2NDC:0498-2520-022 TABLET, COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/07/201201/04/2017
Labeler - North Safety Products LLC (019777263)
Registrant - North Safety Products LLC (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products LLC019777263repack(0498-2520, 0498-2521)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack(0498-2520), pack(0498-2521)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(0498-2520, 0498-2521)

 
North Safety Products LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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