Label: ANTACID ANTIGAS REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid

  • NDC Code(s): 55319-755-12
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 October 31, 2022

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  • Active ingredient (in each 10 mL)

    Aluminum hydroxide (equiv. to dried gel USP) 400 mg

    Magnesium Hydroxide 400 mg

    Simethicone 40 mg

  • Purpose

    Antacid

    Antacid

    Antigas

  • Uses

    • for the relief of
      • acid indigestion
      • heartburn
      • sour stomach
      • upset stomach associated with these symptoms
      • pressure and bloating commonly referred to as gas
      • overindulgence in food and drink
  • Warnings

    Do not take

    more than 120 mL in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physican

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet

    ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if

    symptoms last more than 2 weeks.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

     In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • shake well before using
    • mL = milliliter
    • do not take more than 60 mL in 24 hours or use the maximum dosage for more than 2 weeks
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • adults and children12 years and older: take 10-20 mL as needed, between or after meals, at bedtime, or as directed by a doctor
    • children under 12 years of age: do not use
  • Other information

    • each 10 mL contains: magnesium 180 mg, potassium 5 mg sodium 4 mg
    • store between  20-25°C (68-77°F).Avoid freezing 
  • Inactive ingredients

    benzyl alcohol, carboxymethylcellulose sodium, flavor,  FD&C red #40, glycerin, microcrystalline cellulose, potassium citrate, propylene glycol, purified water, sodium saccharin,, sorbitol, xanthan gum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS IN MYLANTA® REGULAR STRENGTH*

    REGULAR STRENGTH

    Antacid & Anti-Gas Relief

    Multi-Symptom Relief

    Aluminum Hydroxide - Antacid

    Magnesium Hydroxide -Antacid

    Simethicone - Antigas

    For Fast Relief of:

    • Heartburn
    • Acid Indigestion
    • Pressure
    • Bloating

    Oral Suspension

    Alcohol-Free

    CHERRY FLAVOR

    FL OZ (mL)

    ††This product is not manufactured or distributed by McNeil Consumer Pharmaceuticals Co., distributor of Mylanta® Regular Strength.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS, NC 28105


  • Product Label

    Aluminum Hydroxide 400 mg, Magnesium Hydroxide 400 mg, Simethicone 40 mg

    FAMILY WELLNESS Regular Strength Antacid & Antigas Relief

  • INGREDIENTS AND APPEARANCE
    ANTACID ANTIGAS  REGULAR STRENGTH
    aluminum hydroxide, magnesium hydroxide, simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-755
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 10 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-755-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201806/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33106/30/201806/30/2025
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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