Label: HUMCO MILK OF MAGNESIA- magnesium hydroxide suspension
- NDC Code(s): 0395-1672-16
- Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated March 17, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- WARNINGS Ask a doctor before use if you have.
- Stop use and ask a doctor.
- When using this product.
- Keep out of reach of children.
(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
- Inactive ingredient.
- Principal display panel
INGREDIENTS AND APPEARANCE
HUMCO MILK OF MAGNESIA
magnesium hydroxide suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-1672 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:0395-1672-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/31/2019 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-1672) , analysis(0395-1672) , pack(0395-1672) , label(0395-1672)