HUMCO MILK OF MAGNESIA- magnesium hydroxide suspension
Humco Holding Group, Inc.

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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Humco Milk of Magnesia USP

Drug Facts

Active ingredient

Magnesium Hydroxide 400 mg per teaspoon (5 mL)

Purpose

Antacid/Saline Laxative

Use

As an antacid: helps relieve acid ingestion, heartburn and sour stomach.

As a laxative: For the temporary relief of occasional constipation. Bowel movement is generally produced in 1.2 to 6 hours.

WARNINGS

Ask a doctor before use if you have.

Abdominal pain, nausea, vomiting, kidney desease, are on a magnesium restricted diet, a sudden change in bowel habits lasting longer than 14 days, if you are taking prescription drugs. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor.

If you have rectal bleeding or have no bowel movement after using this product. this could be signs of a serious codition, if you need to use a laxative for more than one week. Frequent or prolonged use may result in the dependence on laxatives.

When using this product.

As an antacid, do not take more than the maximum recomended daily dose in a 24 hr. period or take the maximum dose for more than two weeks, except under the advise of a doctor. May have laxative effect.

If pregnant or breastfeeding ask a health professional before use.

Keep out of reach of children.

In the case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions
(Shake well before use)

As an antacid: Adults and children 12 yrs. of age and older: 1 to 3 teaspoonfuls with a little water, or as directed by a doctor.

As a laxative: Adults and children 12 yrs. of age and older: 1 to 4 tablespoonfuls followed by a full 8 oz. glass of water.

Children 6 thru 11 yr. of age: 1 to 2 tablespoonfuls followed by a full 8 oz. glass of water.

children 2 thru 5 yrs. of age: 1 to 3 teaspoonfuls followed by a full 8 oz. glass of water.

Children under 2 yrs. of age: consult a doctor before use.

Other information

acid neutralizing capacilty: 10.0 mEq per teaspoon.

keep tightly closed and avoid freezing.

Inactive ingredient.

Purified water

Principal display panel

Label

image description

HUMCO MILK OF MAGNESIA
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-1670
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-1670-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/14/2017	03/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	03/25/1998	03/31/2019

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(0395-1670) , analysis(0395-1670) , pack(0395-1670) , label(0395-1670)

Revised: 6/2020

Document Id: a7afd3e8-c04a-5eba-e053-2995a90ae084

Set id: e4d0a831-91fd-42bc-8bbd-5d5defce6509

Version: 3

Effective Time: 20200609

Humco Holding Group, Inc.