Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e80aad16-fbce-49a5-8258-ad2a90af599c
Route
ORAL
Published
Effective Date 2012-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Hydroxide (1200 mg)
Inactive Ingredients
Water Sodium Hypochlorite Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1997-06-19

Description

Magnesium hydroxide 1200 mg

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Magnesium hydroxide 1200 mg

Uses
  • relieves occasional constipation (irregularity)
  • usually 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 • a sudden change in bowel habits that lasts over 14 days

Directions
  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • dose may be taken once a day, in divided doses, or as directed by a doctor

  • drink a full glass (8oz) of liquid with each dose

adults and children 12 years and older

2 to 4 tabletspoonfuls (TBSP)

children 6 to 11 years

1 to 2 tablespoonfuls (TBSP)

children under 6 years

ask a doctor





Other Information
  • each 15 mL tablespoonful contains:  magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use
  • TAMPER-EVIDENT:  Do not use if imprinted neckband is missing or broken.



Active Ingredients

Magnesium hydroxide 1200 mg

Inactive Ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Principal Display Panel
Compare to

Active Ingredient in

Phillips Milk of Magnesia



Rugby Milk of Magnesia is distributed by

Rugby Laboratories, Inc.

Duluth, GA   30097





Additional barcode labeling by;

Physicians Total Care, Inc.

Tulsa, Oklahoma    74146







Milk of Magnesia

Magnesium Hydroxide 1200mg

Saline Laxative

Mint Flavor



Net Contents

16 fl oz (473 mL)



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
If Pregnant Or Breast Feeding

ask a health professional before use.

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.

Keep This and All Drugs Out of the Reach of Children

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


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • usually 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 • a sudden change in bowel habits that lasts over 14 days

Directions
  • shake well before use
  • do not exceed the maximum recommended daily dose in a 24 hour period
  • dose may be taken once a day, in divided doses, or as directed by a doctor

  • drink a full glass (8oz) of liquid with each dose

adults and children 12 years and older

2 to 4 tabletspoonfuls (TBSP)

children 6 to 11 years

1 to 2 tablespoonfuls (TBSP)

children under 6 years

ask a doctor





Other Information (Other information)
  • each 15 mL tablespoonful contains:  magnesium 500 mg
  • store at room temperature and avoid freezing
  • close cap tightly after use
  • TAMPER-EVIDENT:  Do not use if imprinted neckband is missing or broken.



Active Ingredients

Magnesium hydroxide 1200 mg

Inactive Ingredients

flavor, purified water, saccharin sodium, sodium hypochlorite

Principal Display Panel
Compare to

Active Ingredient in

Phillips Milk of Magnesia



Rugby Milk of Magnesia is distributed by

Rugby Laboratories, Inc.

Duluth, GA   30097





Additional barcode labeling by;

Physicians Total Care, Inc.

Tulsa, Oklahoma    74146







Milk of Magnesia

Magnesium Hydroxide 1200mg

Saline Laxative

Mint Flavor



Net Contents

16 fl oz (473 mL)



Stop Use and Ask A Doctor If (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
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)

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

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, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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