Label: GENTLE LAXATIVE- magnesium hydroxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Active ingredient (in each 15 mL)

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • usually produces bowel movement in 1/2 to 6 hours

  • Warnings

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet
    • stomach pain, nausea, or vomiting
    • a sudden change in bowel habits that lasts over 14 days

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

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    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 use
    • do not exceed the maximum recommended daily dose in a 24 hour period
    • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
    • follow each dosage with a full glass (8 oz) of liquid
    adults and children 12 years and older30 mL to 60 mL
    children 6 to 11 years15 mL to 30 mL
    children under 6 yearsask a doctor

  • Other information

    • each 15 mL contains: magnesium 500 mg, sodium 6 mg
    • store at room temperature tightly closed
    • do not freeze
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, D&C red no. 28, flavor, glycerin,
    microcrystalline cellulose, purified water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum

    Questions or Comments?

    1-800-540-3765

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1634
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorpink (opaque light pink) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1634-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/01/2020
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0363-1634)
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