NDC 51645-291

SINE OFF SINUS/COLD MEDICINE

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride

SINE OFF SINUS/COLD MEDICINE is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Gemini Pharmaceuticals, Inc.. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID51645-291_7482ddf8-8357-3818-e053-2991aa0a5778
NDC51645-291
Product TypeHuman Otc Drug
Proprietary NameSINE OFF SINUS/COLD MEDICINE
Generic NameAcetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-07-05
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameGemini Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51645-291-24

2 BLISTER PACK in 1 BOX (51645-291-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2010-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51645-291-24 [51645029124]

SINE OFF SINUS/COLD MEDICINE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-05

NDC 51645-291-12 [51645029112]

SINE OFF SINUS/COLD MEDICINE TABLET, FILM COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-05
Marketing End Date2019-03-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:3ba3d54c-e252-494f-a31f-7478cfb349cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052679
  • NDC Crossover Matching brand name "SINE OFF SINUS/COLD MEDICINE" or generic name "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    63029-216BCacetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride
    63029-221BCacetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride
    51467-006CHILDRENS COLTALINACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
    51467-005COLTALINAcetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
    51467-010Extra Fast ColtalinAcetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
    47682-120Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
    47682-189Medique Medicidin DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
    47682-190Otis Clapp ValihistACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
    0924-0091PhysiciansCare AllergyAcetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride
    51645-291SINE OFFACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE

    Trademark Results [SINE OFF]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SINE OFF
    SINE OFF
    86372443 4798222 Live/Registered
    Gemini Pharmaceuticals, Inc.
    2014-08-20

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