NUVALU EPSOM SALT (MAGNESIUM SULFATE (HEPTAHYDRATE)) GRANULE [J C SALES]

NUVALU EPSOM SALT (MAGNESIUM SULFATE (HEPTAHYDRATE)) GRANULE [J C SALES]
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NDC 72520-001-12
Set ID 9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd
Category HUMAN OTC DRUG LABEL
Packager J C SALES
Generic Name
Product Class
Product Number
Application Number PART334
  • DRUG FACTS

  • Active Ingredients

    Magnesium sulfate (heptahydrate) 100%

  • Purpose

     Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 30 mins 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. Laxatives may affect how other drugs work.

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • do not exceed more than 2 doses per day; If necessary repeat dosage in 4 hours.

    agedose
    adults and children 12
    years and older
    2-4 level teaspoons dissolved
    in a full glass (8oz) of water
    children 6 to 11 years1-2 level teaspoons dissolved
    in a full glass (8oz) of water

    Not recommended for children under 6 years of age.

  • Other Information

    • magnesium content 493 mg per teaspoon (5 grams)

    Store in cool dry place out of direct sunlight.

  • Inactive Ingredients

    none 

  • SPL UNCLASSIFIED SECTION

    UNSCENTED

    MULTI-PURPOSE

    Magnesium sulfate U.S.P

    Saline laxative

    TAMPER RESISTANT PACKAGING

    Caution: Do not use if heat sealed carton is improperly sealed

    Package sold by weight not volume. Some settling of content may occur during shipment. If caking occurs, tap pouch gently to free granules.

    Distributed by JC Sales,

    Los Angeles, CA 90058

    Made in China

  • Packaging

    Epsom001

  • INGREDIENTS AND APPEARANCE
    NUVALU EPSOM SALT 
    magnesium sulfate (heptahydrate) granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72520-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72520-001-12624 g in 1 BOX; Type 0: Not a Combination Product11/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33411/30/2018
    Labeler - J C SALES (610969578)

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