NDC | 0498-2421-01, 0498-2421-10, 0498-2421-25, 0498-2421-50, 0498-2422-01, 0498-2422-10, 0498-2422-25, 0498-2422-50 |
Set ID | 49b1e49f-e09e-4db5-9230-bf69b6881f82 |
Category | HUMAN OTC DRUG LABEL |
Packager | Honeywell Safety Products USA, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredients (in each tablet)
- Purposes
- Uses
-
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.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
- Pain Stoppers regular
- Pain Stoppers 100CT
- Pain Stoppers 250CT
- Pain Stoppers 500CT
-
INGREDIENTS AND APPEARANCE
PAIN STOPPERS
acetaminophen, caffeine, aspirin, salicylamide tabletProduct 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 tabletProduct 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)