LUCKY EPSOM SALT (MAGNESIUM SULFATE) GRANULE [DELTA BRANDS INC]

LUCKY EPSOM SALT (MAGNESIUM SULFATE) GRANULE [DELTA BRANDS INC]
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NDC 20276-330-04, 20276-330-16, 20276-330-19, 20276-330-22
Set ID 39bf1448-8aa1-5856-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART334
  • Active Ingredient

    Magnesium sulfate USP 100%

  • Purpose

    Saline laxative

  • Uses

    ■ relieves 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 restricted diet ■ stomach pain, nausea or vomiting ■ noticed a sudden change in bowel habits that lasts more than 2 weeks

  • Ask a doctor or pharmacist before using if you are

    presently taking a prescription drug

  • When using this product

    ■ do not use more than directed

  • Stop use and ask a doctor if

    ■ you have rectal bleeding or failure to have a bowel movement after use. This may indicate 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

    ■do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours

    age dose

    adults and children 2-4 level teaspoons dissolved

    12 years and older in a full glass (8oz) of water

    children 6 to 1-2 level teaspoons dissolved

    11 years in a full glass (8oz) of water

    Not recommended for children under 6 years of age

  • Inactive ingredients

    NONE

  • Other information

    ■ each teaspoon contains magnesium 493 mg

  • Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    LUCKY EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-330
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM100 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CATION (UNII: T6V3LHY838)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-330-19544 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    2NDC:20276-330-16454 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    3NDC:20276-330-041810 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    4NDC:20276-330-22624 g in 1 POUCH; Type 0: Not a Combination Product09/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/05/2016
    Labeler - Delta Brands Inc (102672008)

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