TOPCARE MILK OF MAGNESIA- magnesium hydroxide suspension 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topco Associates LLC. Milk of Magnesia Drug Facts

Active ingredient (in each 15 mL)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

relieves occasional constipation (irregularity)
generally 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 more than 2 weeks

Ask a doctor or pharmacist before use if you are

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

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 right away (1-800-222-1222).

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, use dose cup provided
mL = milliliter

adults and children 12 years and older

30 mL to 60 mL

children 6 to 11 years

15 mL to 30 mL

children under 6 years

ask a doctor

Other information

each 15 mL contains: calcium 20 mg, magnesium 595 mg, potassium 2 mg and sodium 3 mg
does not meet USP requirements for preservative effectiveness
store at 20-25 °C (68-77 °F)
close cap tightly after use
avoid freezing

Inactive ingredients

anhydrous citric acid, D&C red #28, flavor, glycerin, purified water, sorbitol solution, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

STIMULANT FREE

Milk of Magnesia

SALINE LAXATIVE

MAGNESIUM HYDROXIDE, 1200 mg per 15 mL

Comfortable, cramp free relief

ALCOHOL 0.4%

CHERRY FLAVOR

COMPARE TO PHILLIPS’® WILD CHERRY active ingredient

12 FL OZ (355 mL)

#1 Doctor recommended saline laxative active ingredient

TopCare Milk of Magnesia image
TOPCARE MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-949
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color PINK (Opaque Light pink) Score     
Shape Size
Flavor CHERRY (wild cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-949-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 02/20/2006
Labeler - Topco Associates LLC (006935977)

Revised: 5/2016
Document Id: 6b7b2837-fa5f-44b0-b6e9-d04fc2f11559
Set id: 8ba1891f-e6bc-4ef0-ba4b-27f07572fdbe
Version: 6
Effective Time: 20160517
 
Topco Associates LLC