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    NDC 49483-0347-24 Comfort-Time 500; 60; 15 mg/1; mg/1; mg/1 Details

    Comfort-Time 500; 60; 15 mg/1; mg/1; mg/1

    Comfort-Time is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Time Cap Labs, Inc. The primary component is ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE.

    Product Information

    NDC 49483-0347
    Product ID 49483-347_7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
    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 Comfort-Time
    Proprietary Name Suffix n/a
    Non-Proprietary Name Acetaminophen, Caffeine, and Pyrilamine Maleate
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 500; 60; 15
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
    Labeler Name Time Cap Labs, Inc
    Pharmaceutical Class Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part343
    Listing Certified Through 2024-12-31

    Package

    NDC 49483-0347-24 (49483034724)

    NDC Package Code 49483-347-24
    Billing NDC 49483034724
    Package 24 TABLET, FILM COATED in 1 BLISTER PACK (49483-347-24)
    Marketing Start Date 2018-12-14
    NDC Exclude Flag N
    Pricing Information N/A
    << 49483-0343-44 49483-0349-00 >>

    Contents

    Standard Product Labeling (SPL)/Prescribing Information SPL e94a26a2-36e5-4e1e-aea1-24e035c98043 Details

    Revised: 12/2018
    Document Id: 7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
    Set id: e94a26a2-36e5-4e1e-aea1-24e035c98043
    Version: 3
    Effective Time: 20181214