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NDC 72520-0001-12 NuValu Epsom Salt 100 g/100g Details
NuValu Epsom Salt 100 g/100g
NuValu Epsom Salt is a ORAL GRANULE in the HUMAN OTC DRUG category. It is labeled and distributed by J C SALES. The primary component is MAGNESIUM SULFATE HEPTAHYDRATE.
Product Information
| NDC | 72520-0001 |
|---|---|
| Product ID | 72520-001_493339b8-694f-4736-829b-b0ea025890e3 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | NuValu Epsom Salt |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Magnesium sulfate (heptahydrate) |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GRANULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | g/100g |
| Substance Name | MAGNESIUM SULFATE HEPTAHYDRATE |
| Labeler Name | J C SALES |
| Pharmaceutical Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 72520-0001-12 (72520000112)
| NDC Package Code | 72520-001-12 |
|---|---|
| Billing NDC | 72520000112 |
| Package | 624 g in 1 BOX (72520-001-12) |
| Marketing Start Date | 2018-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd Details
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
SPL UNCLASSIFIED SECTION
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 older | 2-4 level teaspoons dissolved in a full glass (8oz) of water |
| children 6 to 11 years | 1-2 level teaspoons dissolved in a full glass (8oz) of water |
Not recommended for children under 6 years of age.
Other Information
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
INGREDIENTS AND APPEARANCE
| NUVALU EPSOM SALT
magnesium sulfate (heptahydrate) granule |
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| Labeler - J C SALES (610969578) |