Label: MILK OF MAGNESIA- milk of magnesia suspension
- NDC Code(s): 55154-9412-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0121-0527
- 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 January 9, 2018
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- SPL UNCLASSIFIED SECTION
A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC).Close
- Inactive Ingredients
A suspension of magnesium hydroxide. Each 10 mL (2 teaspoonfuls) of Milk of Magnesia Concentrate is equivalent to 30 mL of Milk of Magnesia yielding 2400 mg of magnesium hydroxide and providing not less than 60 mq/10 mL of acid-neutralizing capacity (ANC). Inactive Ingredients: Flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, silicone defoamer, sodium citrate, sodium saccharin, sodium salts of polymerized alkylnaphthalenesulfonic acid, sorbitol solution, and sucrose.
Sodium Content: 19 mg/10 mL.Close
- FOR USE AS AN ANTACID
For the temporary relief of heartburn, upset stomach, sour stomach, and/or acid indigestion.
Adults and children 12 years of age and over - Oral dosage is 5 mL (1 teaspoonful) with a little water up to four times daily or as directed by a physician. Children under 12 years of age - Consult a physician. SHAKE WELL BEFORE USING.
The maximum recommended daily dosage of this product is 20 mL (4 teaspoonfuls). Do not take more than this dosage in a 24-hour period or use this dosage for more than 2 weeks unless directed by a physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician. May have a laxative effect.
- FOR USE AS A LAXATIVE
For relief of occasional constipation. This product generally produces bowel movement in ½ to 6 hours.
Drink a full glass (8 oz) of liquid following each dose. Adults and children 12 years of age and over - Oral dosage is 10 to 20 mL (2 to 4 teaspoonfuls); Children 6 to under 12 years of age - Oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls); Children 2 to under 6 years of age - Oral dosage is 5 mL (1 teaspoonful) or as directed by a physician. The dose may be taken as a single daily dose or in divided doses. Children under 2 years of age - Consult a physician. SHAKE WELL BEFORE USING.
Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use longer than 1 week unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. Discontinue use and consult your physician. Do not use this product if you have kidney disease or if you are on a magnesium restricted diet unless directed by a physician.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
DRUG INTERACTION PRECAUTION
Antacids may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.
- HOW SUPPLIED
Milk of Magnesia Concentrate (white suspension-lemon flavored) overbagged with 5 cups per bag, NDC 55154-9412-5.
Zanesville, OH 43701Close
Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). PROTECT FROM FREEZING.Close
- SPL UNCLASSIFIED SECTION
Greenville, SC 29605
Zanesville, OH 43701
- Principal Display Panel
Milk of Magnesia Concentrate
- INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
milk of magnesia suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9412(NDC:0121-0527) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg in 10 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PYRROBUTAMINE NAPHTHALENE DISULFONATE (UNII: 144X0H6HW6) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color WHITE Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-9412-5 5 in 1 BAG 06/07/2011 1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/07/2011 Labeler - Cardinal Health (188557102) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK(55154-9412)