MILK OF MAGNESIA ORIGINAL  - magnesium hydroxide liquid 
TYA Pharmaceuticals

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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Active ingredient (in each 15 mL tablespoonful)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

Warnings

• kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days taking a prescription drug. This product may interact with certain prescription drugs. • 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 ask a health professional before use.

Ask a doctor before use if you have




Ask a doctor or pharmacist before use if you are



Stop use and ask a doctor if



If pregnant or breast-feeding,

In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

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 adults and children 12 years and older: 2 to 4 tablespoonfuls children 6 to 11 years: 1 to 2 tablespoonfuls children under 6 years: ask a doctor









Other information

• magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use • each 15 mL tablespoonful contains:


TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

Inactive ingredients

purified water, sodium hypochlorite

MILK OF MAGNESIA ORIGINAL (MAGNESIUM HYDROXIDE) LIQUID

Label Image
MILK OF MAGNESIA ORIGINAL  
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0649(NDC:57896-649)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64725-0649-116 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2000
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-0649) , REPACK(64725-0649)

Revised: 5/2012
Document Id: 0b22d1e4-6b18-48b1-890e-9d2c147f0acc
Set id: 04245f2b-56c5-4d2f-bb77-de96d3579070
Version: 2
Effective Time: 20120502
 
TYA Pharmaceuticals