Label: TROPICAL PANNED- calcium carbonate, simethicone 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 11, 2016

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  • ACTIVE INGREDIENT

    Calcium carbonate 750 mg

    Simethicone 80 mg

  • PURPOSE

    Purpose

    Antacid

    Anti-gas

  • INDICATIONS & USAGE

    Uses for the relief of:

    • Acid indigestion
    • Heartburn
    • Sour stomach
    • Upset stomach associated with these symptoms
    • Bloating, pressure, or stuffed feeling commonl referred to as gas
  • WARNINGS

    Warnings

    Do not use if you've 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 presently taking a prescription drug. Antacids may interact with certain prescription drugs.

  • WHEN USING

    When using this product

    • Do not take more than 5 chewable tablets in a 24 hour period
    • Do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervsion of a physician.
    • 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

    • Adutls and children 12 years and older: Fully chew then swallow 1 or 2 chewable tablets are symptoms occur, or as directed by a doctor.
    • Children under 12 years: consult a doctor.
    • Do not take more than 5 chewable tablets in a 24 hour period.
  • OTHER SAFETY INFORMATION

    Other information

    • each chewable tablet contains: calcium 330 mg
    • store at room temperature. Avoid excessive heat above 40C (104F)
    • Close cap tightly after use
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C Red #40 Aluminum Lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methyl paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, water, white wax

  • QUESTIONS

    Questions

    1-800-986-0369

  • PRINCIPAL DISPLAY PANEL

    AS Heartburn 32ct

  • INGREDIENTS AND APPEARANCE
    TROPICAL PANNED 
    calcium carbonate, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Coloryellow, orange, pinkScorescore with uneven pieces
    ShapeROUNDSize70mm
    FlavorLEMON, ORANGE, STRAWBERRYImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-225-3232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/19/2014
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/19/2014
    Labeler - BestCo Inc. (002149136)
    Registrant - Bayer (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-225)
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