Label: ALKA-SELTZER FRUIT CHEWS- calcium carbonate tablet, chewable

  • NDC Code(s): 0280-4095-01, 0280-4095-36, 0280-4095-60
  • Packager: Bayer HealthCare LLC, Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each chewable tablet)

    Calcium carbonate 750 mg

    Close
  • Purpose

    Antacid

    Close
  • Uses

    for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
    Close
  • Warnings

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

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

    When using this product

    • do not take more than 10 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

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

    Keep out of reach of children.

    Close
  • Directions

    • adults and children 12 years and over: chew and swallow 1-2 chewable tablets every 2 to 4 hours as symptoms occur, or as directed by a doctor
    • children under 12 years: consult a doctor
    • do not take more than 10 chewable tablets in a 24-hour period
    Close
  • 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.
    Close
  • Inactive ingredients

    acacia, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C red #40 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, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide

    Close
  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzer.com

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Bayer HealthCare LLC
    P.O. Box 1910
    Morristown, NJ 07962-1910 USA

    Close
  • PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Label

    NEW!

    Orange
    Lemon
    Strawberry

    Alka-
    Seltzer®

    Calcium Carbonate /
    Antacid

    FRUIT CHEWS

    FOR FAST RELIEF OF

    • HEARTBURN
    • ACID INDIGESTION
    • UPSET STOMACH

    36 CHEWABLE TABLETS

    Principal Display Panel - 36 Tablet Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER FRUIT CHEWS 
    calcium carbonate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0280-4095
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    calcium carbonate (calcium cation) calcium carbonate 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    acacia  
    yellow wax  
    pigment red 5  
    carnauba wax  
    citric acid monohydrate  
    starch, corn  
    corn syrup  
    .alpha.-tocopherol, dl-  
    FD&C blue no. 1  
    FD&C red no. 40  
    aluminum oxide  
    FD&C yellow no. 5  
    FD&C yellow no. 6  
    hydrogenated coconut oil  
    medium-chain triglycerides  
    methylparaben  
    phosphoric acid  
    propylparaben  
    propylene glycol  
    water  
    shellac  
    sodium benzoate  
    sorbic acid  
    sorbitol  
    lecithin, soybean  
    sucrose  
    titanium dioxide  
    Product Characteristics
    Color ORANGE, YELLOW, PINK Score no score
    Shape OVAL Size 18mm
    Flavor ORANGE, LEMON, STRAWBERRY Imprint Code AS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-4095-36 36 in 1 BOTTLE
    2 NDC:0280-4095-60 60 in 1 BOTTLE
    3 NDC:0280-4095-01 1 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part331 03/15/2013
    Labeler - Bayer HealthCare LLC, Consumer Care (785159372)
    Close