EPSOM SALT SALINE LAXATIVE- magnesium sulfate, unspecified form powder

EPSOM SALT SALINE LAXATIVE by

Drug Labeling and Warnings

EPSOM SALT SALINE LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Compania Farmaceutica, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each packet)

Magnesium sulfate 12 g

Purpose

Saline laxative

Uses

• For relief of occasional constipation
• This product generally produces bowel movement in 1/2 to 6 hours.

Warnings

Do not use

• if you have kidney disease unless directed by a doctor
• when abdominal pain, nausea, or vomiting are present unless directed by a doctor
• for more than 1 week unless directed by a doctor

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet
• noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

Adults and children 12 years of age and over: Drink a full glass (8 ounces) of liquid with each 1 packet dose.

Other information

• Magnesium Content 1.2g
• Store at 86˚F/30˚C or cooler

Inactive ingredients

none

Package Labeling:

INGREDIENTS AND APPEARANCE

EPSOM SALT SALINE LAXATIVE 
magnesium sulfate, unspecified form powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71230-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED FORM	12 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71230-002-12	12 g in 1 POUCH; Type 0: Not a Combination Product	11/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/15/2018

Labeler - Compania Farmaceutica, S.A. de C.V. (816053340)