PREMIER VALUE MILK OF MAGNESIA- magnesium hydroxide suspension

Premier Value Milk of Magnesia by

Drug Labeling and Warnings

Premier Value Milk of Magnesia by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PREMIER VALUE MILK OF MAGNESIA 
magnesium hydroxide suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-850
Route of Administration	ORAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-850-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	06/02/2021

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(68016-850) , analysis(68016-850) , pack(68016-850) , label(68016-850)