MAGNESIUM CITRATE SOLUTION [BETTER LIVING BRANDS LLC]

MAGNESIUM CITRATE SOLUTION [BETTER LIVING BRANDS LLC]
PDF | XML

NDC 21130-693-38
Set ID ff255690-ce80-4dc7-b5d9-7ec7c3384462
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • Active Ingredient

    Magnesium citrate 1.745g per fl oz

  • Purpose

    Saline laxative

  • Use

    for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours

  • Warnings

  • Ask a doctor before use if you have

    • kidney disease
    • a magnesium or potassium-restricted diet
    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week
  • Ask a doctor or pharmacist before use if you are

    taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

  • Stop use and ask a doctor if

    you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

  • 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 right away.

  • Directions

    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divided doses

    adults and children 12 years of age and over - 6.5 to 10 fl oz maximum in 24 hours

    children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age - 2 to 3 fl oz maximum in 24 hours

    children under 2 years of age - ask a doctor

    discard unused product within 24 hours of opening bottle

  • Other information

    • magnesium content 290 mg per 1 fl oz (30 mL)
    • sodium content 48 mg per 1 fl oz (30 mL)
    • store at temperatures between 46º and 86º F (8º and 30º C)
  • Inactive ingredients

    cherry flavor,citric acid, potassium bicarbonate, purified water, red 40, sodium saccharin

  • principal display panel

    Signature Care Oral Solution

    Magnesium Citrate

    Effervescent Saline Laxative

    Alcohol content 0.0031% (from flavoring)

    Cherry flavor

    DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

    10 FL OZ (296 mL)

    Distributed by

    Better Living Brands LLC

    P.O. Box 99 Pleasantion, CA 94566-0009

    1-888-723-3929

    www.betterlivingbrandsLLC.com

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-693
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-693-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/20/2015
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(21130-693)

Related Drugs