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NDC 66689-0053-99 Milk of Magnesia 400 mg/5mL Details
Milk of Magnesia 400 mg/5mL
Milk of Magnesia is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by VistaPharm, Inc.. The primary component is MAGNESIUM HYDROXIDE.
MedlinePlus Drug Summary
Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
Related Packages: 66689-0053-99Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Magnesium Hydroxide
Product Information
| NDC | 66689-0053 |
|---|---|
| Product ID | 66689-053_774c9bcf-e112-42d3-a5e0-2f23173cf6ed |
| Associated GPIs | 46100010101820 |
| GCN Sequence Number | 003026 |
| GCN Sequence Number Description | magnesium hydroxide ORAL SUSP 400 MG/5ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 07950 |
| HICL Sequence Number | 001329 |
| HICL Sequence Number Description | MAGNESIUM HYDROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Milk of Magnesia |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Magnesium Hydroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/5mL |
| Substance Name | MAGNESIUM HYDROXIDE |
| Labeler Name | VistaPharm, Inc. |
| Pharmaceutical 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 |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part331 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 66689-0053-99 (66689005399)
| NDC Package Code | 66689-053-99 |
|---|---|
| Billing NDC | 66689005399 |
| Package | 10 TRAY in 1 CASE (66689-053-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE |
| Marketing Start Date | 2018-04-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 61e230d7-2848-4f08-b258-1de584720200 Details
DESCRIPTION
Inactive Ingredients
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
KEEP OUT OF REACH OF CHILDREN
HOW SUPPLIED
PRINCIPAL DISPLAY PANEL - 30 mL Cup Label
INGREDIENTS AND APPEARANCE
| MILK OF MAGNESIA
magnesium hydroxide suspension |
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| Labeler - VistaPharm, Inc. (116743084) |