CAREONE MILK OF MAGNESIA- magnesium hydroxide liquid 
American Sales Company

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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American Sales Company Milk of Magnesia Drug Facts

Active ingredient (in each 15 mL TBSP)

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

•
shake well before use
•
do not exceed the maximum recommended daily dose in a 24 hour period
•
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
•
TBSP = tablespoonful

adults and children 12 years and older

2 to 4 TBSP.

children 6 to 11 years

1 to 2 TBSP.

children under 6 years

ask a doctor

Other information

•
each tablespoon (15 mL) contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg
•
store at 20o-25oC (68o-77oF)
•
keep tightly closed
•
avoid freezing

Inactive ingredients

light mineral oil, peppermint oil, purified water, saccharin sodium

Principal Display Panel

Compare to the Active Ingredient in Phillips’® Milk of Magnesia

MILK OF MAGNESIA

SALINE LAXATIVE / Magnesium Hydroxide

MINT FLAVOR

Comfortable, Cramp Free Relief

Dependable Overnight Relief

Stimulant Free

Sugar Free

Milk of Magnesia Front Label
Milk of Magnesia Back Label
CAREONE MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-332
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (MAGNESIUM CATION and HYDROXIDE ION) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
WATER 
SACCHARIN SODIUM 
PEPPERMINT OIL 
Product Characteristics
ColorWHITE (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-332-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/27/2012
Labeler - American Sales Company (809183973)

Revised: 11/2012
Document Id: 7dee2a74-ca93-4e4a-b456-92b0bc52dfd4
Set id: 7dee2a74-ca93-4e4a-b456-92b0bc52dfd4
Version: 1
Effective Time: 20121114
 
American Sales Company