MILK OF MAGNESIA- magnesium hydroxide suspension 
Paddock Laboratories, 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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Perrigo Milk of Magnesia USP Drug Facts

Active ingredient

Magnesium Hydroxide 80 mg per mL

Purposes

Antacid/Saline Laxative

Uses

As an antacid helps relieve acid indigestion, heartburn and sour stomach.
As a laxative relieves occasional constipation. This product generally produces bowel movement in 1/2 to 6 hrs.

Warnings

Ask a doctor before use if you have

kidney disease
a magnesium-restricted diet
abdominal pain
nausea
vomiting
change in bowel habits persisting for more than 2 weeks

Ask a doctor before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

as an antacid, do not take more than the maximum recommended daily dose in a 24 hr. period or take the maximum dose for more than 2 weeks, except under the advice of a doctor. May have laxative effect.

Stop use and ask a doctor if

you use this product as a laxative and:

have rectal bleeding
do not have a bowel movement after use
use for 1 week (do not use for longer than 1 week unless directed by a doctor)

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
In case of eye contact, flush eyes with running water for 15 minutes.

Directions:

Shake well before using.

As an antacid:

Adults and children 12 yrs. and older:

1 to 3 teaspoons with a little water, up to four times a day, or as directed by a doctor.

As a laxative:

Adults and children 12 yrs. and older:

2 to 4 tablespoons followed by a full 8 oz. glass of water.

Children 6 to 11 yrs. of age:

1 to 2 tablespoons followed by a full 8 oz. glass of water.

Children 2 to 5 yrs. of age:

1 to 3 teaspoons followed by a full 8 oz. glass of water.

Children under 2 yrs. of age:

Consult a doctor before use.

Other information

Each teaspoon contains: calcium 20 mg, magnesium 165 mg, potassium 5 mg, sodium 9 mg
Acid neutralizing capacity: 10 mEq. per teaspoon
Keep tightly closed and avoid freezing.

Inactive ingredient

Purified Water

Questions?

1-800-719-9260 Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

NDC 0574-0018-16

Milk of Magnesia USP

Antacid – Saline Laxative

CAUTION: Do not use if tamper evident seal is broken or missing. This product is sealed with either a shrink band around cap imprinted “sealed for your protection” or breakaway cap ring.

Shake well before using. Keep from freezing.

473 mL (one pint)

Perrigo Milk of Magnesia
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-0018
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-0018-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33110/01/197709/30/2015
Labeler - Paddock Laboratories, LLC (967694121)

Revised: 4/2015
 
Paddock Laboratories, LLC