PAIN STOPPERS- acetaminophen, caffeine, aspirin, salicylamide tablet PAIN STOPPERS REGULAR- acetaminophen, caffeine, aspirin, salicylamide tablet

Pain Stoppers Regular by

Drug Labeling and Warnings

Pain Stoppers Regular by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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 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

• 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: consult a doctor

Other Information

• store at a controlled room temperature 15 o-30 oC (59 o-86 oF)
• TAMPER EVIDENT-DO NOT USE IF OPEN 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

Pain Stoppers 100CT

Pain Stoppers 250CT

Pain Stoppers 500CT

INGREDIENTS AND APPEARANCE

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 - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-2421, 0498-2422)