MILK OF MAGNESIA- magnesium hydroxide liquid 
Kinray 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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Drug Facts

Active Ingredient (in each 5 mL Tablespoon)

Magnesium Hydroxide 400 mg

Purpose

Saline laxative

Use

relieves occasional constipation (irregularity).
This product generally produces bowel movement in ½ to 6 hours.

Warnings

Ask a doctor before use if you have

kidney disease
stomach pain, nausea, or vomiting
a sudden change in bowel habits that persist over a period of 2 weeks
a magnesium - restricted diet

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 one 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.

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
mL = milliliter, 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

TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
Store at room temperature 15º - 30ºC (59º - 86ºF)
keep tightly closed
keep from freezing
each tablespoon (5 mL) contains: sodium 4 mg
each tablespoon (5 mL) contains: magnesium 166 mg

Inactive ingredients

carboxymethylcellulose sodium, citric acid, D&C red #28, flavor, glycerin, microcrystalline cellulose, water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum.

Principal Display Panel

Milk of Magnesia Label
MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPINK (PINK) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-131-04355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2014
Labeler - Kinray LLC (012574513)

Revised: 10/2014
Document Id: 4fa9508a-e960-4ff8-8439-4689a93d8eb2
Set id: 83f0408e-a463-409b-be4d-9a1ce3647523
Version: 1
Effective Time: 20141001
 
Kinray LLC