drug facts

drug facts
SPL v6
SPL
SPL Set ID f55da148-81a3-49cc-bbde-6aef920b8903
Routes
oral topical
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
magnesium cation (1 g)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-01-31

Purpose

 Saline laxative

Description

Magnesium sulfate USP 100%


Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Purpose

 Saline laxative

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 in a full glass (8oz) of water



Not recommended for children under 6 years of age.
Other Information
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredients

None

Description

Magnesium sulfate USP 100%

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate

Saline Laxative

  • Relieves Occasional Constipation
  • Soaking Aid For Minor Sprain and Bruises

NET WT  oz kg

TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Package Label
HARRIS TEETER Epsom Salt
Active Ingredient

Magnesium sulfate USP 100%

Questions Or Comments?

call 1-877-753-3935 Monday- Friday 9AM-5PM EST

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
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.

If Pregnancy Or Breast Feeding,

 ask a health professional before use.

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.


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Purpose

 Saline laxative

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 in a full glass (8oz) of water



Not recommended for children under 6 years of age.
Other Information (Other information)
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredients

None

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate

Saline Laxative

  • Relieves Occasional Constipation
  • Soaking Aid For Minor Sprain and Bruises

NET WT  oz kg

TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Package Label
HARRIS TEETER Epsom Salt
Active Ingredient (Active ingredient)

Magnesium sulfate USP 100%

Questions Or Comments? (Questions or comments?)

call 1-877-753-3935 Monday- Friday 9AM-5PM EST

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children. (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.

If Pregnancy Or Breast Feeding, (If pregnancy or breast-feeding,)

 ask a health professional before use.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

 presently taking a prescription drug.


Advanced Ingredient Data


Raw Label Data

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