Label: CRANE SAFETY ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 73408-092-33, 73408-920-33
  • Packager: Crane Safety LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 31, 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 pharmacists before use if you are

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

    When usung 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 exceed19 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 59-86°F (15-30°C) in a dry place
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

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

    *may contain

  • QUESTIONS

    Questions or comments? 877.506.4291

  • PRINCIPAL DISPLAY PANEL

    Antacid

    Crane Safety

    Heartburn, Indigestion

    Pull to Open

    Calcium Carbonate 420 MG

    Chew or Crush Tablets Completely Before Swallowing

    100 Tablets

    Tamper Evident

    Sealed Packets

    C2 Antacid

  • PRINCIPAL DISPLAY PANEL

    Antacid

    Crane Safety

    Heartburn, Indigestion

    Pull to Open

    Calcium Carbonate 420 MG

    Chew or Crush Tablets Completely Before Swallowing

    100 Tablets

    Tamper Evident

    Sealed Packets

    C3 Antacid

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-092
    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
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    ACACIA (UNII: 5C5403N26O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code FR;8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-092-3350 in 1 BOX01/17/202003/01/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/17/202003/01/2021
    CRANE SAFETY ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-920
    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
    SORBITOL (UNII: 506T60A25R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-920-3350 in 1 BOX01/17/202005/31/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/17/202005/31/2024
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(73408-092, 73408-920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(73408-920, 73408-092)
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