Label: CITROMA- magesium citrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 23, 2021

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  • 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

    Warnings for this product

  • Do Not use

    if you are on a low salt diet

  • Ask A Doctor

    • kidney disease
    • a magnesium or sodium restricted diet
    • abdorominal 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

    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

    citric acid, lemon oil, polyethylene glycol,  purified water, sodium bicarbonate, sodium saccharin, sucrose

  • Adverse Reaction

    Distributed by

    Better Living Brands LLC

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

    1-888-723-3929

    www.betterlivingbrandsLLC.com

  • principal display panel

    Signature

    Care

    Quality

    Guaranteed

    Oral Solution

    Magnesium

    Citrate

    EFFERVESCENT SALINE

    LAXATIVE

    LEMON FLAVOR

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

    10 FL OZ (296 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CITROMA 
    magesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-667
    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)  
    LEMON OIL (UNII: I9GRO824LL)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-667-38296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/06/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/06/2003
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(21130-667)
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