Active Ingredient (In Each 5 Ml) One Teaspoonful)
Magnesium Hydroxide 400 mg
Milk Of Magnesia
FDA Label NDC 53807-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Milk Of Magnesia (NDC 53807-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml) one teaspoonful), purpose, use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative/Antacid
Use
Laxative
- relieves occasional constipation (irregularity).
- generally produces bowel movement in ½ to 6 hours.
- relieves acid indigestion, sour stomach, heartburn.
Antacid
Ask A Doctor Before Use If You Have
- kidney disease
- stomach pain, nausea or vomiting
- notice a sudden change in bowel habits that persists over a period of 2 weeks
- a magnesium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. Antacid may interact with certain prescription drugs.
When Using This Product
- it may have a laxative effect
- do not exceed the maximum recommended daily dosgae in a 24-hour period
Stop Use And Ask A Doctor If
Laxative
- you have rectal bleeding or failure to have a bowel movement after use. These may indicate a serious condition.
- you need to use a laxative for more than one week
- symptoms last for more than 2 weeks.
Antacid
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
Directions
- shake well before use
| Laxative use: | Antacid use | |
Do not use dosage cup for ages under 12 years. Follow each dose with a full glass (8 oz) of liquid. | Do not use dosage cup. Follow each dose with a little water. | |
| adults and children 12 years and older | 2-4 TBSP (30-60 mL) once a day | 1-3 tsp (5-15 mL) up to 4 times a day |
| 6 to 11 years | 1-2 TBSP (15-30 mL) once a day | ask a doctor |
| 2 to 5 years | 1-3 tsp (5-15 mL) once a day | ask a doctor |
| under 2 years | ask a doctor | ask a doctor |
Other Information
- TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
- Store at room temperature 15° - 30°C (59° - 86°F)
- keep tightly closed
- keep from freezing
- each teaspoon (5 mL) contains: magnesium 166 mg
- each teaspoon (5 mL) contains: sodium 1 mg
Inactive Ingredients
citric acid, flavor, purified water, sodium hypochlorite.
* Please review the disclaimer below.
