Otc - Active Ingredient
Magnesium Sullfate USP (Epsom Salt)
Epsom Salt
FDA Label NDC 71611-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Click Products Llc for the product Epsom Salt (NDC 71611-009). 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, dosage & administration, indications & usage, otc - keep out of reach of children, warnings, 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 - Purpose
Internal Use ...............Saline laxative
External Use ..............Soaking Solution
Dosage & Administration
For internal Use as laxative:
- do not exceed more than 2 doses per day
- may be taken as a single daily dose or in divided doses
- dissolve each dose in a full (8 ounces)of liquid
- Age = Aduls and children 12 years and older ............Dose: 2 to 4 level teaspoons (10 to 22 grams) daily
- Children 6 and under 12 years....................................Dose: 1 to 2 level teaspoons (5 to 10 grams) daily
- Not recommended for children under 6 years of age.
Indications & Usage
USES
Internal
- Relieves occasional constipation (irregularity)
- Generally produces bowel movements in 1/2 to 6 hours
External - RElieves pain from minor prains and bruises
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where ther is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.
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
- As laxative: you have rectal bleeding or fail to have a bowel movement after use.
- This may indicate a serious condition
- You need to use a laxative for more than 1 week.
- you have redness, irritation, swelling or infection occurs
- hot or warm soaks should not be used by individuals with diabeted except with the advise of a pyhsician.
Ask doctor or pharmacist before use if you are presently taking any other drug. take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
When using this product, do not use more than directed.
Stop and consult a doctor if:
As a soaking solution if:
If pregnant or breast-feedig , ask a health professional before use.
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALT CAN BE APPLIED FOR EXTERNAL USE ONLY.
Inactive Ingredient
n/a
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