NDC 49483-347

Comfort-Time

Acetaminophen, Caffeine, And Pyrilamine Maleate

Comfort-Time is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Time Cap Labs, Inc. The primary component is Acetaminophen; Caffeine; Pyrilamine Maleate.

Product ID49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
NDC49483-347
Product TypeHuman Otc Drug
Proprietary NameComfort-Time
Generic NameAcetaminophen, Caffeine, And Pyrilamine Maleate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-11-30
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameTime Cap Labs, Inc
Substance NameACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active Ingredient Strength500 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49483-347-24

24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)
Marketing Start Date2018-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49483-347-24 [49483034724]

Comfort-Time TABLET, FILM COATED
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-14

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:e94a26a2-36e5-4e1e-aea1-24e035c98043
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1597298
  • NDC Crossover Matching brand name "Comfort-Time" or generic name "Acetaminophen, Caffeine, And Pyrilamine Maleate"

    NDCBrand NameGeneric Name
    49483-347Comfort-TimeAcetaminophen, Caffeine, and Pyrilamine Maleate
    67751-145MidolACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
    73097-007MidolACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
    0280-8005Midol CompleteACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
    52904-841Midol Completeacetaminophen, caffeine, and pyrilamine maleate
    66715-9745Midol CompleteAcetaminophen, Caffeine, and Pyrilamine Maleate
    70262-303Midol CompleteACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
    70264-012MIDOL COMPLETEACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE

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