NDC 63654-605

Cold Medicine XL3

Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride

Cold Medicine XL3 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 ID63654-605_e2c35f3a-1d7b-bc51-e053-2a95a90a4159
NDC63654-605
Product TypeHuman Otc Drug
Proprietary NameCold Medicine XL3
Generic NameAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-06-27
Marketing CategoryOTC 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
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63654-605-20

2 BLISTER PACK in 1 BOX (63654-605-20) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2022-06-27
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Cold Medicine XL3" 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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