Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 86c26e3c-27f8-4c59-ac5a-10c6435131bc
Route
ORAL
Published
Effective Date 2009-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (2.62 g)
Inactive Ingredients
Water Citric Acid Monohydrate Saccharin Sodium Anhydrous Potassium Bicarbonate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-07-31

Description

Magnesium Citrate 1.745g per fl oz

Purpose

saline laxative


Medication Information

Purpose

saline laxative

Description

Magnesium Citrate 1.745g per fl oz

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

Warnings

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 one week

Directions

Adults and Children 12 years of age and older             1/2 to 1 bottle (10 fl oz). Drink a full 8 oz glass of liquid with each dose.                                                                                 The dose may be taken as a single daily dose or in divided doses.

children 6 to under 12 years of age                               1/3 to 1/2 bottle with a full 8 oz glass of liquid.

children under 6 years of age                                        consult a doctor



Active Ingredient

Magnesium Citrate 1.745g per fl oz

Other Information

store at controlled room temperature

protect from excessive heat and freezing

discard unused product within 24 hours of opening bottle



Inactive Ingredients

Citric acid, flavors, potassium bicarbonate, saccharin sodium, purified water

Questions Or Comments?

1-866-534-4631

Principal Display Panel
When Using This Product

do not exceed the maximum recommended daily dosage in a 24 hour period

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after use .

These could be a sign of a serious condition.

you need to use a laxative more than one week.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug

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.


Structured Label Content

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours

Purpose

saline laxative

Warnings

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 one week

Directions

Adults and Children 12 years of age and older             1/2 to 1 bottle (10 fl oz). Drink a full 8 oz glass of liquid with each dose.                                                                                 The dose may be taken as a single daily dose or in divided doses.

children 6 to under 12 years of age                               1/3 to 1/2 bottle with a full 8 oz glass of liquid.

children under 6 years of age                                        consult a doctor



Active Ingredient (Active ingredient)

Magnesium Citrate 1.745g per fl oz

Other Information

store at controlled room temperature

protect from excessive heat and freezing

discard unused product within 24 hours of opening bottle



Inactive Ingredients

Citric acid, flavors, potassium bicarbonate, saccharin sodium, purified water

Questions Or Comments? (Questions or Comments?)

1-866-534-4631

Principal Display Panel
When Using This Product (when using this product)

do not exceed the maximum recommended daily dosage in a 24 hour period

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or no bowel movement after use .

These could be a sign of a serious condition.

you need to use a laxative more than one week.

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

ask a health professional before use.

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

Keep This and All Drugs Out of the Reach of Children. (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.


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Raw Label Data

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