Label: EPSOM SALTS RELIEF- magnesium sulfate heptahydrate granule
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Contains inactivated NDC Code(s)
NDC Code(s): 22431-124-01, 22431-124-02, 22431-124-03, 22431-124-04 - Packager: Blue Cross Laboratories, Inc.
- 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 November 15, 2022
If you are a consumer or patient please visit this version.
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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 is 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 longer than 1 week
Ask a doctor of pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
If pregnant or breast-feeding, as 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.
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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 RELIEF
magnesium sulfate heptahydrate granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-124 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:22431-124-01 1810 g in 1 BAG; Type 0: Not a Combination Product 04/24/2015 2 NDC:22431-124-02 454 g in 1 BAG; Type 0: Not a Combination Product 04/24/2015 3 NDC:22431-124-03 454 g in 1 CARTON; Type 0: Not a Combination Product 04/24/2015 4 NDC:22431-124-04 907 g in 1 BAG; Type 0: Not a Combination Product 04/24/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/09/2010 Labeler - Blue Cross Laboratories, Inc. (008298879) Registrant - Blue Cross Laboratories, Inc. (008298879)
