Label: ANTACID FRUIT FLAVOR CHEWS- calcium carbonate lozenge

  • 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 January 26, 2018

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Calcium Carbonate 750 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses Relieves

    Heartburn

    Sour stomach

    Acid indigestion

    Upset stomach due to these symptoms

  • WARNINGS

    Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.

  • WHEN USING

    Do not take more than 5 chewable tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the supervision of a physician.

    When using this product constipation may occur.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years and older chew and swallow 1 to 2 chewable tablets every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24 hours. Children under 12 years consult a doctor.

  • OTHER SAFETY INFORMATION

    Other information

    Each chewable tablet contains: calcium 300 mg, magnesium 1 mg

    Contains soy

    Contains FD&C Yellow No. 5 (tartrazine) as a color additive

  • INACTIVE INGREDIENT

    Inactive ingredients: Beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, pregelatinized corn starch, propyl paraban, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, soybean oil, sucrose and titanium dioxide.

  • QUESTIONS

    Questions? Call 1-800-245-2898 Monday - Friday, 9AM to 4PM EST

  • PRINCIPAL DISPLAY PANEL

    Family Wellness Antacid Flavor Chews 36ct

  • INGREDIENTS AND APPEARANCE
    ANTACID FRUIT FLAVOR CHEWS 
    calcium carbonate lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-017
    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
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colororange (Orange, Pink, Yellow) Scoreno score
    ShapeROUNDSize14mm
    FlavorFRUIT (Lemon, Orange, Strawberry) Imprint Code FC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-017-3636 in 1 BOTTLE; Type 0: Not a Combination Product01/26/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/26/2018
    Labeler - Family Dollar (024472631)
    Registrant - Bestco Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco Inc.002149136manufacture(55319-017)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!