Label: UNISHIELD ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 49314-1013-3, 49314-1023-3
  • Packager: Unishield
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • 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

    ■ are taking a prescription drug. Antacids may interact with certain prescription drugs.

    ■ Have kidney disease

  • WHEN USING

    When using this product

    ■ do not take more than 19 tablets in a 24 hour period. If symptoms persist for more than 2 weeks, stop using this product and see a doctor.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children: (12 years and older) Chew 2 tablets every 2 - 3 hours as symptoms occur, repeat hourly if needed. Do not exceed 19 tablets in 24 hours.

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■calcium content per tablet: 168 mg

    ■ phenylketonurics: each tablet may contain 1.5 mg phenylalanine

    ■ store at room temperature 59º-86ºF (15º-30ºC) in a dry place

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    I nactive ingredients

    aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*

    *may contain

  • QUESTIONS

    Questions or comments? 1-800-480-5855

  • PRINCIPAL DISPLAY PANEL

    Unishield

    Antacid

    Calcium Carbonate 420 mg

    100 Tablets/2 Tablets Per Packet

    Calcium Rich Chewable Tablets

    Pull To Open

    • Relieves upset stomach, and indigestion
    and heartburn

    Compare active ingredient to: TUMS®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    Unishield Antacid Label 1

  • PRINCIPAL DISPLAY PANEL

    Unishield

    Antacid

    Calcium Carbonate 420 mg

    100 Tablets/2 Tablets Per Packet

    Calcium Rich Chewable Tablets

    Pull To Open

    • Relieves upset stomach, and indigestion
    and heartburn

    Compare active ingredient to: TUMS®

    Registered Trademark of McNeil Consumer Healthcare

    Tamper Evident Unit Dose Packets

    Unishield Antacid Label 2

  • INGREDIENTS AND APPEARANCE
    UNISHIELD ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINT (Peppermint) Imprint Code FR;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1023-350 in 1 BOX03/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/01/202112/24/2023
    UNISHIELD ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-1013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SORBITOL (UNII: 506T60A25R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-1013-350 in 1 BOX03/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00103/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(49314-1013, 49314-1023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(49314-1013, 49314-1023)
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