Search by Drug Name or NDC

    NDC 63654-0605-20 Cold Medicine 325; 2; 5 mg/1; mg/1; mg/1 Details

    Cold Medicine 325; 2; 5 mg/1; mg/1; mg/1

    Cold Medicine 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 Information

    NDC 63654-0605
    Product ID 63654-605_e2c35f3a-1d7b-bc51-e053-2a95a90a4159
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Cold Medicine
    Proprietary Name Suffix XL3
    Non-Proprietary Name Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 325; 2; 5
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name Selder, S.A. de C.V.
    Pharmaceutical Class Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 63654-0605-20 (63654060520)

    NDC Package Code 63654-605-20
    Billing NDC 63654060520
    Package 2 BLISTER PACK in 1 BOX (63654-605-20) / 10 TABLET in 1 BLISTER PACK
    Marketing Start Date 2022-06-27
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e2c35fae-9dd6-51f2-e053-2995a90a1e9e Details

    Revised: 7/2022