GREEN GUARD MAXIMUM STRENGTH STOMACH RELIEF (CALCIUM CARBONATE 750 MG) TABLET, CHEWABLE [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD MAXIMUM STRENGTH STOMACH RELIEF (CALCIUM CARBONATE 750 MG) TABLET, CHEWABLE [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-850-33, 47682-850-36, 47682-850-99
Set ID 692e09bc-2842-adb9-e053-2991aa0aec49
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART331
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium Carbonate USP 750mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses

    relieves

    • acid indigestion
    • sour stomach
    • heartburn
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    • the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a doctor
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you

    • are taking a preceription drug. Antacida may interact with certain prescription drugs.
    • have kidney disease
  • WHEN USING

    When using this product

    • do not take more than 10 tablets in 24 hours
    • if pregnant, do not take more than 6 tablets in 24 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • chew or crush tablets completely before swallowing
    • do not swallow tablets whole
    • do not take for symptoms that persisit for more than 2 weeks unless adived by a doctor

    Adults and children: (12 years and over) Chew 2 to 4 tablets as symptoms occur or as directed by a doctor

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains 300 mg of elemental calcium
    • 5 calories per tablet
    • store at room temperature 59-86ºF (15-30ºC) in a dry place
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    assorted flavors, dextrose, FD&C blue #1, FD&C red #40, magnesium stearate, maltodextrin, mineral oil

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Maximum Strength Stomach Relief Label

    Maximum Strength

    Stomach relief™

    Pull to Open

    Tire Para Abrir

    Heartburn, indigestion

    las agruras, la indigestion

    Calcium Carbonate 750mg

    Carbonato de Calcio 750mg

    Assorted Berry

    Bayas surtidas

    Green Guard®

    50 Packets of 2 Tablets

    100 Tablets

    Order #2280

    Distributed by Green Guard ®

    St Louis, MO 63045

    Green Guard

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD MAXIMUM STRENGTH STOMACH RELIEF 
    calcium carbonate 750 mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorgray, purple, redScoreno score
    ShapeROUNDSize15mm
    FlavorSTRAWBERRY, BLUEBERRY, RASPBERRYImprint Code RH;031
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-850-992 in 1 PACKET; Type 0: Not a Combination Product04/09/2018
    2NDC:47682-850-3675 in 1 BOX04/09/2018
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-850-3350 in 1 BOX04/09/2018
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/09/2018
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(47682-850) , repack(47682-850)

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