Label: ALKA SELTZER- 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 12, 2016

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  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Calcium carbonate 750 mg

  • PURPOSE

    Purpose

    Antacid

  • INDICATIONS & USAGE

    Uses for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • WARNINGS

    Warnings

    Do not useif 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 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 supervision 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

    • adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as 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 300 mg
    • contains FD&C Yellow No. 5 (tartrazine) as a color additive
    • store at room temperature. Avoid humidity.
    • close cap tightly after use.
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax

  • QUESTIONS

    Questions or comments?

    1-800-986-0369 (Mon-Fri 9AM-5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka Seltzer HB 90 ct

  • INGREDIENTS AND APPEARANCE
    ALKA SELTZER 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52642-226
    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
    Colorpink, yellow, orangeScorescore with uneven pieces
    ShapeROUNDSize70mm
    FlavorSTRAWBERRY, LEMON, ORANGEImprint Code AS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52642-226-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2013
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/08/2013
    Labeler - BestCo Inc. (002149136)
    Registrant - Bayer (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    BestCo Inc.002149136manufacture(52642-226)
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