NDC 0498-2521

Pain Stoppers EX

Acetaminophen, Caffeine, Aspirin

Pain Stoppers EX is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Honeywell Safety Products Usa, Inc. The primary component is Acetaminophen; Caffeine; Aspirin.

Product ID0498-2521_7484d27d-f80e-1917-e053-2a91aa0afc92
NDC0498-2521
Product TypeHuman Otc Drug
Proprietary NamePain Stoppers EX
Generic NameAcetaminophen, Caffeine, Aspirin
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2017-01-02
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameHoneywell Safety Products USA, Inc
Substance NameACETAMINOPHEN; CAFFEINE; ASPIRIN
Active Ingredient Strength250 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0498-2521-10

100 PACKET in 1 BOX (0498-2521-10) > 2 TABLET, COATED in 1 PACKET (0498-2521-01)
Marketing Start Date2017-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0498-2521-01 [00498252101]

Pain Stoppers EX TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-02

NDC 0498-2521-50 [00498252150]

Pain Stoppers EX TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-02

NDC 0498-2521-25 [00498252125]

Pain Stoppers EX TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-02

NDC 0498-2521-10 [00498252110]

Pain Stoppers EX TABLET, COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-02

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN250 mg/1

OpenFDA Data

SPL SET ID:f1e4ccd8-1767-48fd-9049-560089029771
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308297
  • Pharm Class PE
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
  • NUI Code
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

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