Label: EPSOM SALT BABY BEAUTY- magnesium sulfate, unspecified granule
- NDC Code(s): 71611-010-01, 71611-010-02, 71611-010-03, 71611-010-04
- Packager: Click Products LLC
- 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.
Updated March 23, 2020
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- ACTIVE INGREDIENT
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
- KEEP OUT OF REACH OF CHILDREN
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
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 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.
As a soaking solution if:
- 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.
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EPSOM SALT BABY BEAUTY
magnesium sulfate, unspecified granule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71611-010 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED 100 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71611-010-02 907 g in 1 BOX; Type 0: Not a Combination Product 10/19/2017 2 NDC:71611-010-03 1361 g in 1 BAG; Type 0: Not a Combination Product 10/19/2017 3 NDC:71611-010-01 454 g in 1 BAG; Type 0: Not a Combination Product 10/19/2017 4 NDC:71611-010-04 1814 g in 1 BAG; Type 0: Not a Combination Product 10/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/19/2017 Labeler - Click Products LLC (080766174) Establishment Name Address ID/FEI Business Operations PRIYAL COSMETICS 675482356 manufacture(71611-010)