Label: ASSURED EPSOM SALT- magnesium sulfate granule
Contains inactivated NDC Code(s)
NDC Code(s): 51140-101-01
- Packager: Hefei Yatai Daily Chemical Products Co., Ltd.
- 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.
Updated December 24, 2019
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
DOSAGE & ADMINISTRATION
- do not exceed more than 2 doses per day
- drink a full glass (8 ounces) of liquid with each dose
- dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.
adults and children 12 years and over - 2 to 4 level teaspoons (10 to 20 grams) daily
children 6 to under 12 year - 1 to 2 level teaspoons (5 to 10 grams) daily
children under 6 year - consult a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ASSURED EPSOM SALT
magnesium sulfate granule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51140-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 100 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51140-101-01 454 g in 1 BAG; Type 0: Not a Combination Product 03/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/30/2016 Labeler - Hefei Yatai Daily Chemical Products Co., Ltd. (654641724) Registrant - Hefei Yatai Daily Chemical Products Co., Ltd. (654641724) Establishment Name Address ID/FEI Business Operations Hefei Yatai Daily Chemical Products Co., Ltd. 654641724 manufacture(51140-101)