Label: FLAVOR 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 February 16, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient (in each chew)

    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.

    Do not take more than 5 chews in a 24 hour period, or use the maxiumum dosage for more than 2 weeks, except under the advice and supervision of a physician.

  • 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

    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 year sand older chew and swallow 1 to 2 chews every 2-4 hours as needed. Do not exceed 5 chews in 24 hours. Children under 12 years consult a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Beeswax, carmine, carnauba wax, citric acid, 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, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide. Soybean oil and corn starch are used as processing aids.

  • OTHER SAFETY INFORMATION

    Other information

    • Each chew contains: calcium 300mg, magnesium 1mg
    • Contains soy
    • Store between 20 to 25 C (68 to 77 F) in a dry place
  • QUESTIONS

    Questions?

    Call 1-800-245-2898 Monday - Friday 9AM - 4PM EST

  • PRINCIPAL DISPLAY PANEL

    Walgreens Asst FC 36ct

  • INGREDIENTS AND APPEARANCE
    FLAVOR CHEWS 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0011
    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
    Coloryellow, pink, orangeScorescore with uneven pieces
    ShapeROUNDSize70mm
    FlavorORANGE, LEMON, STRAWBERRYImprint Code FC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0011-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/23/2015
    Labeler - Walgreens (008965063)
    Registrant - BestCo Inc. (002149136)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(0363-0011)
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