Daily Care Epsom Salt
FDA Label NDC 78107-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 1 Source Trading Llc for the product Daily Care Epsom Salt (NDC 78107-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                              Purpose
Magnesium Sulfate (heptahydrate) 100%                         Saline laxative

Otc - Purpose

Uses

  • For relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours

Otc - Keep Out Of Reach Of Children

If pregnant or bread feeding, aska 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.

Indications & Usage

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

Warnings

Warnings

Ask a doctor before use if 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

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 year  - 1 to 2 level teaspoons (5 to 10 grams) daily

    children under 6 year - consult a doctor

Inactive Ingredient

None Available

Package Label.Principal Display Panel

2 (2)

2 (2)

1 (1)

1 (1)

* Please review the disclaimer below.