Mirafast Soft Chews Ui1615762

Mirafast Soft Chews Ui1615762
SPL v1
SPL
SPL Set ID 2cee67dd-b71f-32b8-e063-6394a90ae864
Route
ORAL
Published
Effective Date 2025-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1200 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Corn Syrup Hydrogenated Coconut Oil Lecithin, Soybean Sucrose Water

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: red Size: 2 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-17

Description

Magnesium hydroxide USP 1200mg

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Magnesium hydroxide USP 1200mg

Uses

relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours.

Directions
  • drink a full glass (8 oz) of liquid with each dose.
  • dose may be taken as a single daily dose, in divided doses, or as directed by a doctor.
  • do not exceed the maximum recommended daily dose in a 24 hour period

adults and children 12 years of age and over 2 to 4 chews
children 6 to under 12 years of age 1 to 2 chews
children 4 to 6 years of age 1 chew
children under 4 years of age ask a doctor

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

If Pregnant Or

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 right away.

Other Information
  • each chew contains: magnesium 500mg, sodium 1mg
  • store between 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat and humidity.
  • Do not use if pouch is torn or open
Mirafast Soft Chews

Inactive Ingredients

corn syrup, FD&C red no. 40 aluminum lake, flavors, glycerin, hydrogenated coconut oil, soy lecithin, sucrose, water.

Questions Or Comments?

Questions or comments? 1-800-647-2529

Stop Use and Ask A Doctor

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of 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.

Active Ingredients (in Each Tablet)

Magnesium hydroxide USP 1200mg

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
  • a sudden change in bowel habits that lasts over 14 days
Ask A Doctor Or Pharmacist Before Use If You Are

Ask a doctor or pharmacist before use if you are taking a prescription drug.

This product may interact with certain prescription drugs.


Structured Label Content

Uses

relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 to 6 hours.

Purpose

Saline laxative

Directions
  • drink a full glass (8 oz) of liquid with each dose.
  • dose may be taken as a single daily dose, in divided doses, or as directed by a doctor.
  • do not exceed the maximum recommended daily dose in a 24 hour period

adults and children 12 years of age and over 2 to 4 chews
children 6 to under 12 years of age 1 to 2 chews
children 4 to 6 years of age 1 chew
children under 4 years of age ask a doctor

Do Not Use (Do not use)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

If Pregnant Or (If pregnant or)

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 right away.

Other Information (Other information)
  • each chew contains: magnesium 500mg, sodium 1mg
  • store between 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat and humidity.
  • Do not use if pouch is torn or open
Mirafast Soft Chews (MiraFAST Soft Chews)

Inactive Ingredients (Inactive ingredients)

corn syrup, FD&C red no. 40 aluminum lake, flavors, glycerin, hydrogenated coconut oil, soy lecithin, sucrose, water.

Questions Or Comments? (Questions or comments?)

Questions or comments? 1-800-647-2529

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

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of 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)

Keep out of reach of children.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Magnesium hydroxide USP 1200mg

Ask A Doctor Before Use If You Have (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
  • a sudden change in bowel habits that lasts over 14 days
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Ask a doctor or pharmacist before use if you are taking a prescription drug.

This product may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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