EPSOM SALTS- magnesium sulfate granule 
Jell Pharmaceuticals Pvt. Ltd.

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.

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Assured Epsom Salts

Active Ingredients Purpose

Magnesium Sulfate (heptahydrate) 100% Saline Laxative

Uses

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.

Warnings

Ask a doctor before use if you have

If pregnant or breast-feeding ask a health profesional before use

Directions

There are no inactive ingredients

Assured

Mutlipurpose

Epsom Salts

Net Wt. 16 oz (454 g)

salts back

salts front

EPSOM SALTS 
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30400-210
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:30400-210-01454 g in 1 POUCH; Type 0: Not a Combination Product07/09/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/09/2019
Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(30400-210)

Revised: 7/2019
Document Id: 8d4443ec-fc8c-0119-e053-2a95a90a68f0
Set id: 8d4443ec-fc8b-0119-e053-2a95a90a68f0
Version: 1
Effective Time: 20190709
 
Jell Pharmaceuticals Pvt. Ltd.