Label: NUVALU EPSOM SALT (magnesium sulfate- heptahydrate granule
- NDC Code(s): 72520-001-12
- Packager: J C SALES
- 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 December 17, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have • kidney disease • a magnesium restricted diet • stomach pain, nausea or vomiting • noticed a sudden change in bowel habits that lasts more than 2 weeks
Ask a doctor or pharmacist before using if you are
presently taking a prescription drug. Laxatives may affect how other drugs work.
When using this product • do not use more than directed
Stop use and ask a doctor if
- you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
- you need to use a laxative for more than 1 week
If pregnant or breast-feeding, ask a health professional before use
- KEEP OUT OF REACH OF CHILDREN
-
Directions
• do not exceed more than 2 doses per day; If necessary repeat dosage in 4 hours.
age dose adults and children 12
years and older2-4 level teaspoons dissolved
in a full glass (8oz) of waterchildren 6 to 11 years 1-2 level teaspoons dissolved
in a full glass (8oz) of waterNot recommended for children under 6 years of age.
- Other Information
- Inactive Ingredients
-
SPL UNCLASSIFIED SECTION
UNSCENTED
MULTI-PURPOSE
Magnesium sulfate U.S.P
Saline laxative
TAMPER RESISTANT PACKAGING
Caution: Do not use if heat sealed carton is improperly sealed
Package sold by weight not volume. Some settling of content may occur during shipment. If caking occurs, tap pouch gently to free granules.
Distributed by JC Sales,
Los Angeles, CA 90058
Made in China
- Packaging
-
INGREDIENTS AND APPEARANCE
NUVALU EPSOM SALT
magnesium sulfate (heptahydrate) granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72520-001 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:72520-001-12 624 g in 1 BOX; Type 0: Not a Combination Product 11/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 11/30/2018 Labeler - J C SALES (610969578)
