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| Product NDC Code | 55154-4061 | ||||
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| Drug Name | Milk of magnesia |
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| Type | Brand | ||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 253017 | ||||
| Application Number | M001 | ||||
| Labeler Name | Cardinal Health 107, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DESCRIPTION Active Ingredient (in each 5 mL = 1 teaspoonful) Magnesium Hydroxide.................400 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS • shake well before use • drink a full glass (8 oz) of liquid with each dose • mL = milliliter Adults and children 12 years of age and older 30 mL to 60 mL Children 6 to 11 years of age 15 mL to 30 mL Children under 6 years of age Consult a physician. or as directed by a physician. • The dose may be taken as a single daily dose or in divided doses.
DIRECTIONS • shake well before use • mL = milliliter • adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician • do not take more than 12 teaspoonfuls (60 mL) in 24-hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients anhydrous citric acid, benzyl alcohol, methylparaben, propylene glycol, propylparaben, purified water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS Uses • For relief of occasional constipation (irregularity) • This product generally produces bowel movement in 1/2 to 6 hours.
INDICATIONS Uses For the relief of • heartburn • sour stomach • acid indigestion • and upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Active Ingredient (in each 5 mL = 1 teaspoonful) Magnesium Hydroxide.................400 mg
Spl product data elements
Usually a list of ingredients in a drug product.Milk of Magnesia Magnesium Hydroxide MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION HYPROMELLOSE 2910 (4000 MPA.S) METHYLPARABEN POTASSIUM CITRATE PROPYLENE GLYCOL WATER CYCLOMETHICONE 4 PROPYLPARABEN SORBITOL SACCHARIN SODIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Milk of Magnesia, USP 2400 mg Magnesium Hydroxide per 30 mL 5 Cups Bag
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.saline laxative/antacid
FOR USE AS A LAXATIVE INDICATIONS Uses • For relief of occasional constipation (irregularity) • This product generally produces bowel movement in 1/2 to 6 hours. WARNINGS Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are • presently taking a prescription drug. This product may interact with certain prescription drugs. Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. DIRECTIONS • shake well before use • drink a full glass (8 oz) of liquid with each dose • mL = milliliter Adults and children 12 years of age and older 30 mL to 60 mL Children 6 to 11 years of age 15 mL to 30 mL Children under 6 years of age Consult a physician. or as directed by a physician. • The dose may be taken as a single daily dose or in divided doses.
FOR USE AS AN ANTACID INDICATIONS Uses For the relief of • heartburn • sour stomach • acid indigestion • and upset stomach associated with these symptoms WARNINGS Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician May have laxative effect Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet Ask a doctor or pharmacist before use if you are • presently taking a prescription drug. Antacids may interact with certain prescription drugs. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. DIRECTIONS • shake well before use • mL = milliliter • adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician • do not take more than 12 teaspoonfuls (60 mL) in 24-hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: consult a physician
HOW SUPPLIED Milk of Magnesia USP 400 mg/5 mL is a white opaque liquid supplied as follows: Overbagged with 5 x 30 mL unit-dose cups per bag, NDC 55154-4061-5 STORAGE Other Information • Protect from freezing • Store at 20° to 25°C (68° to 77°F) Questions or Comments? Call 1-888-655-1505 (toll-free)
Distributed by: VistaPharm, Inc. Largo, FL 33771, USA Distributed by: Cardinal Health Dublin, OH 43017 L55273200519 VP2152R1 09/17
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call 1-888-655-1505 (toll-free)
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Other Information • Protect from freezing • Store at 20° to 25°C (68° to 77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts more than 2 weeks Ask a doctor or pharmacist before use if you are • presently taking a prescription drug. This product may interact with certain prescription drugs. Stop use and ask a doctor if • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. • you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
WARNINGS Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician May have laxative effect Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet Ask a doctor or pharmacist before use if you are • presently taking a prescription drug. Antacids may interact with certain prescription drugs. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API