FDA Label for Milk Of Magnesia Original
View Indications, Usage & Precautions
Milk Of Magnesia Original Product Label
The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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.
Active Ingredient (In Each 30 Ml Cup)
Magnesium hydroxide 2400 mg
Purpose
Saline laxative
Uses
- relieves occasional constipation (irregularity)
- usually 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 over 14 days
- 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
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
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.
Directions
- shake well before use
- do not exceed the maximum recommended daily dose in a 24 hour period
- 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
adults and children 12 years and older | 1 unit dose cup (30 mL) to 2 unit dose cups (60 mL) |
children 6 to 11 years | ½ unit dose cup (15 mL) to 1 unit dose cup (30 mL) |
children under 6 years | ask a doctor |
Other Information
- each 30 mL cup contains: magnesium 1000 mg
- store at room temperature and avoid freezing
- DO NOT USE IF SEAL IS BROKEN
- This drug product is supplied in 30 ml unit dose cups as:
100 cups (10 x 10) ND 60687-429-76
Inactive Ingredients
purified water, sodium hypochlorite
Packaging Information
American Health Packaging unit dose cups (see
Other Information section) contain drug product from Geri-Care Pharmaceuticals as follows:
(2400 mg per 30 mL / 100 UD) NDC 60687-429-76 packaged from NDC 57896-649
Distributed by:
American Health Packaging
Columbus, OH 43217
8442972/0920F
Principal Display Panel – Tray
Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative
FOR INSTITUTIONAL USE ONLY
Store at room temperature
and avoid freezing.
8442972/0920F
Principal Display Panel – Cup
NDC 60687- 429-45
Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative
2400 mg/30 mL
Delivers 30 mL
SHAKE WELL. AVOID FREEZING.
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only
American Health Packaging
Columbus, OH 43217
0442972/0320
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