GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]

GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]
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NDC 51660-070-21, 51660-070-41
Set ID 1cc8add2-55d9-4215-8f7b-07a2a9f45673
Category HUMAN OTC DRUG LABEL
Packager OHM LABORATORIES INC
Generic Name
Product Class
Product Number
Application Number NDA021282
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • Warnings

    Do not use

    for children under 12 years of age

    Ask a doctor before use if you have

    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
    These could be signs of a serious illness.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    do not crush, chew, or break tablet
    take with a full glass of water
    this product can be administered without regard for the timing of meals
    adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    children under 12 years of age: do not use
  • Other information

    Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    store between 20-25°C (68-77°F)
  • Inactive ingredients

    carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

  • Questions?

    (1-800-406-7984)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Sun Pharmaceutical Industries, Inc.
    Cranbury, NJ 08512

  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

    NDC 51660-070-41

    Compare To
    the active ingredient of
    Mucinex®

    ohm®

    Guaifenesin
    Extended-Release Tablets
    600 mg
    Expectorant

    12 Hour

    • Relieves Chest Congestion
    • Thins and Loosens Mucus
    • Immediate and Extended Release

    40 Extended-Release Tablets

    PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code Mxeunic;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-070-211 in 1 CARTON02/08/2018
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51660-070-412 in 1 CARTON02/08/2018
    220 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02128201/08/2018
    Labeler - OHM LABORATORIES INC (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(51660-070)

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