FDA Label for Milk Of Magnesia Concentrate
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 10 ML)
- PURPOSE
- AS AN ANTACID
- AS A LAXATIVE
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 10 ML UNIT-DOSE CUP TRAY LABEL
Milk Of Magnesia Concentrate Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
MANUFACTURED BY
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com
R07/21
Active Ingredient (In Each 10 Ml)
Magnesium hydroxide 2400 mg
Purpose
Saline laxative
As An Antacid
- heartburn
- upset/sour stomach
- acid indigestion
- do not exceed the maximum recommended daily dose of 20 mL in a 24 hour period
- shake well before use
- can be taken with water
- mL = milliliter
| adults and children 12 years of age and over | 5 mL (1 teaspoonful) |
| children under 12 years of age | ask a doctor |
As A Laxative
- relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor. Drink a full glass (8 oz) of liquid with each dose.
- mL = milliliter
| adults and children 12 years and older | 15 mL to 30 mL |
| children under 12 years | ask a doctor |
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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 over 14 days
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use If you are 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 right away.
Other Information
- each teaspoonful (5 mL) contains: magnesium 1000 mg
- Sodium Content: 19 mg/10 mL
- store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
- Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:
NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.
Inactive Ingredients
glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
dihydrate, sodium saccharin, sorbitol, and sucrose.
Questions Or Comments?
Call 1-800-845-8210
Principal Display Panel - 10 Ml Unit-Dose Cup Tray Label
NDC 0121-0940-10
Milk of Magnesia Concentrate
Each 10 mL contains:
Magnesium Hydroxide 2400 mg.
ANTACID/ SALINE LAXATIVE
SHAKE WELL
Package Not Child-Resistant
See Insert
* Please review the disclaimer below.