Label: MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid
- NDC Code(s): 60687-429-45, 60687-429-51, 60687-429-76
- Packager: American Health Packaging
- This is a repackaged label.
- Source NDC Code(s): 57896-649
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL cup)
- Purpose
- Uses
-
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
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
If pregnant or breast-feeding,
ask a health professional before use. -
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
- Inactive ingredients
-
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 57896-649Distributed by:
American Health Packaging
Columbus, OH 432178442972/0920F
- Principal Display Panel – Tray
-
Principal Display Panel – Cup
NDC 60687- 429-45
Original Flavor
Milk of Magnesia
(Magnesium Hydroxide)
Saline Laxative2400 mg/30 mL
Delivers 30 mLSHAKE WELL. AVOID FREEZING.
See package Drug Facts insert for full
prescribing information and storage.For Institutional Use Only
American Health Packaging
Columbus, OH 432170442972/0320
-
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA ORIGINAL
magnesium hydroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60687-429(NDC:57896-649) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 1200 mg in 15 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60687-429-76 10 in 1 CASE 09/01/2020 1 NDC:60687-429-51 10 in 1 TRAY 1 NDC:60687-429-45 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2020 Labeler - American Health Packaging (929561009) Establishment Name Address ID/FEI Business Operations American Health Packaging 929561009 repack(60687-429)
