Label: ARAMARK ANTACID CHEWABLE- calcium carbonate tablet

  • 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 June 1, 2021

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient (in each tablet)
    Calcium Carbonate 420 mg

  • PURPOSE

    Purpose
    Calcium Carbonate ............. Antacid

  • INDICATIONS & USAGE

    Uses:
    For the relief of:
    • heartburn • sour stomach • acid indigestion

  • WARNINGS

    Warnings:Do Not:• take more than 18 tablets in a 24 hour period, or use the maximum dosage of this
       product
    • for more than 2 weeks, except under the advice of a physician

  • STOP USE

    Stop use and ask a doctor if:
    you are currently taking a prescription drug. Antacids may react with certain prescription
    drugs

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children  In case of overfose, get medical help or contact a Poison Control
    Center right away. Prompt medical attention is critical for adults as well as for children
    even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions:
    Adults and children
    12 years of age and older:    		 do not exceed 18 tablets in a 24 hour period,
    or as directed by a doctor
    Children under
    12 years:    		 Consult a doctor

  • OTHER SAFETY INFORMATION

    Other information:
    Tamper Evident. Do not use if packet is torn, cut or opened Store at controlled
    room temperature 15º to 30ºC (59º to 86ºF) Avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Corn starch, sucrose, magnesium stearate, mint, acacia, maltodextrin

  • Package Labeling

    aramark

    100TABLETS         Part # 90233B
    PER BOX

    Antacid Chewable Tablets
    Flavored Antacid Tablet

    Temporary relief of heartburn,
    sour stomach, acid indigestion
    and upset stomach associated
    with these symptoms

    Compare active ingredient to:

    Tums® aramarkuniform.com
    Registered Trademark of Smithkline-Beecham

    MANUFACTURED FOR:

    Aramark
    Lenexa, KS 66219
    866-362-2691

    aramarkuniform.com

    Retain carton for complete product information

    100 Tablet Box

    0303-1 100ct box

    250 Tablet Box

    0303-2 250ct box

    2-Tablet Packet

    0303 2ct Pouch

    res

  • INGREDIENTS AND APPEARANCE
    ARAMARK ANTACID CHEWABLE 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-0303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION420 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINT (UNII: FV98Z8GITP)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code FR8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-0303-150 in 1 BOX05/07/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-0303-2125 in 1 BOX05/07/2021
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/07/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(81238-0303)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION944090448manufacture(81238-0303)
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