Label: EPSOM SALTS- magnesium sulfate granule
- NDC Code(s): 30400-210-01
- Packager: Jell Pharmaceuticals Pvt. 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.
Drug Label Information
Updated July 9, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
Ask a doctor before use if you have
- Kidney Disease
- A magnesium restricted diet
- Abdominal 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 of longer than 1 week
If pregnant or breast-feeding ask a health profesional before use
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DOSAGE & ADMINISTRATION
Directions
- 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 years: 1 to 2 level teaspoons (5 to 10 grams) daily
- children under 6 years: consult a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EPSOM SALTS
magnesium sulfate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30400-210 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:30400-210-01 454 g in 1 POUCH; Type 0: Not a Combination Product 07/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/09/2019 Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(30400-210)