Basics_solimo 602.002/602aa

Basics_solimo 602.002/602aa
SPL v6
SPL
SPL Set ID 787ec4b0-c6c5-44ab-a53d-d6d25304f95e
Routes
ORAL TOPICAL
Published
Effective Date 2025-05-19
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 Completed Since 2018-05-01 Until 2023-01-26

Description

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative


Medication Information

Purpose

Saline Laxative

Description

Magnesium sulfate USP (heptahydrate) 100%

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

for this product

Directions
  • do not exceed recommended daily dosage
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses
  • 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 6 level teaspoons (10 to 30 grams) daily

children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years - consult a doctor

Adverse Reaction

Tamper Evident Packaging:

Caution: This package has been sealed for your protection. Do not use if package is open, torn or mutilated.

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

©2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Other Information
  • each teaspoon (5 grams) contains: magnesium 495 mg
Soaking Directions

For external use as a soaking aid for minor sprains and bruises.

DIRECTIONS:  For a relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water

CAUTION:  If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.  Hot or warm soaks should not be used by individuals with diabetes except on the advice of a phsician.  Keep out of reach of children.

Invactive Ingredient

None

Principal Display Panel

SOLIMO

Epsom Salt

Magnesium Sulfate USP

Saline laxative

Soaking aid

NET WT 8 LB (3.62 kg)

Stop Use and Ask A Doctor If

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a help professional before use.

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 A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.


Structured Label Content

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

Saline Laxative

Warnings

for this product

Directions
  • do not exceed recommended daily dosage
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses
  • 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 6 level teaspoons (10 to 30 grams) daily

children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years - consult a doctor

Adverse Reaction (ADVERSE REACTION)

Tamper Evident Packaging:

Caution: This package has been sealed for your protection. Do not use if package is open, torn or mutilated.

DISTRIBUTED BY:

Amazon.com, Services, Inc

Seattle, WA 98109

1-877-485-0385

©2018 Amazon.com, Inc. or its afiliated.

All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.

Active Ingredient (Active ingredient)

Magnesium sulfate USP (heptahydrate) 100%

Other Information (Other information)
  • each teaspoon (5 grams) contains: magnesium 495 mg
Soaking Directions (soaking directions)

For external use as a soaking aid for minor sprains and bruises.

DIRECTIONS:  For a relaxing bath/soak, generously sprinkle Epsom Salt into warm, running bath water

CAUTION:  If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.  Hot or warm soaks should not be used by individuals with diabetes except on the advice of a phsician.  Keep out of reach of children.

Invactive Ingredient

None

Principal Display Panel (principal display panel)

SOLIMO

Epsom Salt

Magnesium Sulfate USP

Saline laxative

Soaking aid

NET WT 8 LB (3.62 kg)

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. These could be signs of a serious condition.

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 right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a help 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
  • 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 A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.


Advanced Ingredient Data


Raw Label Data

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