Label: BET-R-PREP MAGNESIUM CITRATE ORAL- magnesium citrate solution

  • NDC Code(s): 71890-320-29
  • Packager: Satius Pharmaceuticals, LLC
  • 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 January 29, 2018

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

  • DRUG FACTS

  • Active Ingredient

    Magnesium citrate 1.745g per fl. Oz

    Purpose

    Saline Laxative

  • Uses

    • Relieves occasional constipation (irregularity)
    • Generally produces bowel movement in ½ to 6 hours
  • Warnings

    Do not use

    laxative products for longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • Kidney disease
    • A sodium restricted diet
    • Noticed a sudden change in bowel habits that lasts more than 1 week
    • A magnesium restricted diet
    • Stomach pain, nausea or vomiting

    Ask a doctor or pharmacist before use if you are 

    presently taking a prescription drug.

    When using this product,

    do not exceed the maximum recommended daily dosage in a 24 hour period.

    Stop use and ask a doctor if

    you have rectal bleeding or no 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 (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and older:
    ½ to 1 bottle (10 fl. oz). Drink a full 8 oz. glass of liquid with each dose. The dose may be taken as a single daily dose or in divided doses.
    Children 6 to 11 years of age:
    1/3 to ½ bottle with a full 8 oz. glass of liquid
    Children under 6 years of age: Consult a doctor

  • Other Information

    • Each fluid ounce contains: magnesium 282 mg, sodium 37 mg
    • Store between 46-86 degrees F (8-30 degrees C). Do not refrigerate.
    • Protect from excessive heat and freezing
    • Discard unused product within 24 hours of opening bottle
  • Inactive ingredients

    purified water, citric acid, sodium bicarbonate, saccharin sodium, natural and artificial flavors, zinc gluconate, potassium citrate

  • Questions or comments?

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

  • Package Labeling:

    NewLabel

  • INGREDIENTS AND APPEARANCE
    BET-R-PREP MAGNESIUM CITRATE ORAL 
    magnesium citrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71890-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71890-320-29296 mL in 1 BOTTLE; Type 0: Not a Combination Product11/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/18/2017
    Labeler - Satius Pharmaceuticals, LLC (080518631)