Epsom Salt by TOP CARE (Topco Associates LLC)
Dosage form: granule
Ingredients: MAGNESIUM SULFATE 1g in 1g
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-395
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.
Magnesium sulfate USP 100%
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 1/2 to 6 hours
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 use if you are
presently taking a prescription drug.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
Not recommended for children under 6 years of age.
| 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 in a full glass (8oz) of water
- each teaspoon contains: magnesium 493 mg
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For health and beauty
Magnesium sulfate USP
- a soaking aid for minor sprains and bruises
- a saline laxative for the short-term relief of constipation
Distributed by Topco Associates LLC
Elk Grove Village, IL 60007
TAMPER EVIDENT: DO NOT USE IF HEAT SEALED CARTON IS IMPROPERLY SEALED
TopCare Epsom Salt
magnesium sulfate granule
|Product Type||HUMAN OTC DRUG||Item Code (Source)||NDC:36800-395
|Route of Administration||ORAL, TOPICAL||DEA Schedule||
|Active Ingredient/Active Moiety
|Ingredient Name||Basis of Strength||Strength
|MAGNESIUM SULFATE (MAGNESIUM CATION) ||MAGNESIUM SULFATE||1 g in 1 g
|#||Item Code||Package Description
|1||NDC:36800-395-01||454 g in 1 CARTON
|2||NDC:36800-395-04||1810 g in 1 CARTON
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC MONOGRAPH NOT FINAL||part334||04/30/2014||
|Labeler - TOP CARE (Topco Associates LLC)
TOP CARE (Topco Associates LLC)
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.