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    NDC 76095-0010-20 Cold Medicine 325; 4; 10 mg/1; mg/1; mg/1 Details

    Cold Medicine 325; 4; 10 mg/1; mg/1; mg/1

    Cold Medicine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by MIDWAY IMPORTING INC.. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.

    Product Information

    NDC 76095-0010
    Product ID 76095-010_eb00f3b1-ba62-57ff-e053-2995a90a4787
    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 FORTE
    Non-Proprietary Name Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 325; 4; 10
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
    Labeler Name MIDWAY IMPORTING INC.
    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 M012
    Listing Certified Through 2024-12-31

    Package

    NDC 76095-0010-20 (76095001020)

    NDC Package Code 76095-010-20
    Billing NDC 76095001020
    Package 2 BLISTER PACK in 1 BOX (76095-010-20) / 10 TABLET in 1 BLISTER PACK (76095-010-02)
    Marketing Start Date 2018-02-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 58252f15-485c-3061-e053-2a91aa0a2320 Details

    Revised: 10/2022