NDC 63654-601

Cold Medicine XL3 FORTE

Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride

Cold Medicine XL3 FORTE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Selder, S.a. De C.v.. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID63654-601_8140655a-7195-757c-e053-2a91aa0a259a
NDC63654-601
Product TypeHuman Otc Drug
Proprietary NameCold Medicine XL3 FORTE
Generic NameAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSelder, S.A. de C.V.
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63654-601-10

1 BLISTER PACK in 1 BOX (63654-601-10) > 10 TABLET in 1 BLISTER PACK (63654-601-01)
Marketing Start Date2018-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63654-601-10 [63654060110]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-12

NDC 63654-601-01 [63654060101]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-18

NDC 63654-601-50 [63654060150]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 63654-601-02 [63654060102]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-18

NDC 63654-601-20 [63654060120]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 63654-601-04 [63654060104]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:51dd467b-aae8-41fa-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193293

    • NDC Crossover Matching brand name "Cold Medicine XL3 FORTE" or generic name "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride"

    NDCBrand NameGeneric Name
    58596-002Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-600Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-601Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-605Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    76095-010Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    76095-011Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
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