NDC 51645-269

SINE OFF MAXIMUM STRENGTH

Acetaminophen, Phenylephrine Hydrochloride

SINE OFF MAXIMUM STRENGTH is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Gemini Pharmaceuticals, Inc.. The primary component is Acetaminophen; Phenylephrine Hydrochloride.

Product ID51645-269_71c186a1-82be-2482-e053-2995a90acc1f
NDC51645-269
Product TypeHuman Otc Drug
Proprietary NameSINE OFF MAXIMUM STRENGTH
Generic NameAcetaminophen, Phenylephrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2010-07-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGemini Pharmaceuticals, Inc.
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength500 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51645-269-66

2 BLISTER PACK in 1 BOX (51645-269-66) > 12 TABLET, COATED in 1 BLISTER PACK
Marketing Start Date2010-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51645-269-66 [51645026966]

SINE OFF MAXIMUM STRENGTH TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-05
Marketing End Date2019-12-31

NDC 51645-269-12 [51645026912]

SINE OFF MAXIMUM STRENGTH TABLET, COATED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-07-05
Marketing End Date2017-11-30

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/1

OpenFDA Data

SPL SET ID:e37237f4-20a0-4599-84c8-d96c62062861
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1101534
  • 1101540

    • NDC Crossover Matching brand name "SINE OFF MAXIMUM STRENGTH" or generic name "Acetaminophen, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    51645-269SINE OFF MAXIMUM STRENGTHSINE OFF MAXIMUM STRENGTH
    46084-101ACETAMINOPHEN SINUS CONGESTION AND PAINACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-001Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-002Green Guard Advanced Sinus ReliefACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-158Medi First Plus Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-146Medi First Sinus Pain and PressureACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-148Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    47682-509Otis Clapp MygrexACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
    37808-466Sinus Congestion and PainAcetaminophen, 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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