Label: EQUATE STRAWBERRY LIME ANTACID CHEWS- calcium carbonate tablet, chewable

  • 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 16, 2020

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  • 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 use the maximum dosage for more than 2 weeks, except under the advice and 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
    • Contains FD&C Yellow #5 (tartrazine) as color additive
    • Contains soy
    • Store between 20° to 25°C (68° to 77°F) in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients: Bees wax, carnauba wax, citric acid, confectioner's sugar, corn syrup, ethyl acetate, FD&C Blue #1 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, phosphoric acid, propyl paraben, saccharose, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water.

  • QUESTIONS

    Questions? 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    Equate Strawberry Lime Antacid Chews 60ct

  • INGREDIENTS AND APPEARANCE
    EQUATE STRAWBERRY LIME ANTACID CHEWS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-472
    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
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorgreen (Green and Red) Scoreno score
    ShapeROUNDSize14mm
    FlavorLIME (Lime and Strawberry) Imprint Code FC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-472-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/16/2020
    Labeler - Walmart (051957769)
    Registrant - Bestco LLC (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco LLC002149136manufacture(49035-472)
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