MILK OF MAGNESIA- magnesium hydroxide liquid

Milk of Magnesia by

Drug Labeling and Warnings

Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by H-E-B, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide USP 1200 mg

Purpose

Saline laxative

Use

relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ 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

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

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• do not exceed the maximum recommended daily dose in a 24 hour period
• shake well before use
• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor. Drink a full glass (8 oz) of liquid with each dose.
• for accurate dosing, only use the dosing cup provided
• do not use any other dosing device
• TBSP = Tablespoon, mL = milliliter

• age: dose
• adults and children 12 years and older: 30 mL (2 TBSP) to 60 mL (4 TBSP)
• children 6 to 11 years: 15 mL (1 TBSP) to 30 mL (2 TBSP)
• children under 6 years: ask a doctor

Other information 

• TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
• each tablespoon (15 mL) contains : calcium 20 mg, sodium 1.43 mg, and magnesium 500 mg
• store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.

Inactive ingredients

D&C Red No. 28, flavor, glycerin, purified water, saccharin sodium, xanthan gum.

Questions or comments?

1-855-274-4122

MADE WITH PRIDE & CARE FOR H-E-B®
SAN ANTONIO, TX 78204

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

*Compare to Phillips’® Milk of Magnesia active ingredient
NDC: 37808-026-16
H-E-B®
Milk of  Magnesia
Magnesium Hydroxide USP, 1200 mg
Saline Laxative
Comfortable, Cramp Free Relief

• Sugar Free
• Stimulant Free
• Low Sodium

Contains: Less than
0.5% alcohol

Cherry Flavor
12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

MILK OF MAGNESIA 
magnesium hydroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P)	MAGNESIUM HYDROXIDE	1200 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CHERRY (UNII: BUC5I9595W)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (Pink to Light Pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-026-16	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2019
2	NDC: 37808-026-32	769 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	11/05/2019

Labeler - H-E-B (007924756)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(37808-026)