Magnesium Hydroxide Usp 1200 Mg

Magnesium Hydroxide Usp 1200 Mg
SPL v5
SPL
SPL Set ID d35f1518-bc63-83eb-e053-2995a90ae4bb
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1200 mg)
Inactive Ingredients
Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: rectangle Color: pink Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-17

Description

Active ingredient (in each chew) Magnesium hydroxide USP 1200 mg


Medication Information

Warnings and Precautions

Warnings

Ask a doctor or pharmacist before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks
  • Do not give to children under 5 years of age unless directed by a doctor
Indications and Usage

Uses

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

Directions

  • drink a full glass (8oz) of liquid with each dose
  • dose may be taken as a single daily dose or in divided doses
  • 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 12 years of age - 1 to 2 chews

children under 6 years of age - ask a doctor

Description

Active ingredient (in each chew) Magnesium hydroxide USP 1200 mg

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask doctor if

  • you have rectal bleeding or fail to have a 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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

Section 51727-6

Inactive ingredients: Confectioner's sugar, corn syrup, corn syrup solids, FD&C red no. 40 aluminum lake, glycerine, gum arabic, hydrogenated coconut oil, maltodextrin, natural flavors, propylene glycol, soy lecithin, sucrose, water

Section 51945-4

Section 53413-1

Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 9AM - 4PM EST

Section 53414-9

If you are pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Saline laxative

Section 55106-9

Active ingredient (in each chew)

Magnesium hydroxide USP 1200 mg

Section 60561-8

Other information

  • Each chew contains: magnesium 500 mg
  • Contains soy
  • Calories 15 per chew
  • Store between 20° to 25°C (68° to 77°F) in a dry place
  • Do not use if bag is torn or open

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours
Dosage and Administration (34068-7)

Directions

  • drink a full glass (8oz) of liquid with each dose
  • dose may be taken as a single daily dose or in divided doses
  • 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 12 years of age - 1 to 2 chews

children under 6 years of age - ask a doctor

Warnings and Precautions (34071-1)

Warnings

Ask a doctor or pharmacist before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks
  • Do not give to children under 5 years of age unless directed by a doctor
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • you have rectal bleeding or fail to have a 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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

Section 51727-6 (51727-6)

Inactive ingredients: Confectioner's sugar, corn syrup, corn syrup solids, FD&C red no. 40 aluminum lake, glycerine, gum arabic, hydrogenated coconut oil, maltodextrin, natural flavors, propylene glycol, soy lecithin, sucrose, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 9AM - 4PM EST

Section 53414-9 (53414-9)

If you are pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Saline laxative

Section 55106-9 (55106-9)

Active ingredient (in each chew)

Magnesium hydroxide USP 1200 mg

Section 60561-8 (60561-8)

Other information

  • Each chew contains: magnesium 500 mg
  • Contains soy
  • Calories 15 per chew
  • Store between 20° to 25°C (68° to 77°F) in a dry place
  • Do not use if bag is torn or open

Advanced Ingredient Data


Raw Label Data

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