Label: EPSOM SALTS- magnesium sulfate granule
- NDC Code(s): 52862-202-01
- Packager: International Wholesale Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
-
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
-
INGREDIENTS AND APPEARANCE
EPSOM SALTS
magnesium sulfate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52862-202 Route of Administration TOPICAL, 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:52862-202-01 454 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 Drug M017 07/09/2019 Labeler - International Wholesale Inc. (161872676) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(52862-202)