Label: MILK OF MAGNESIA concentrate
- NDC Code(s): 0054-3567-49, 0054-3567-61
- Packager: West-Ward Pharmaceuticals Corp.
- 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.
Updated May 8, 2015
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- CONCENTRATED Milk of Magnesia (Lemon Flavored)
- Drug Facts
- Active Ingredient per 10 mL
- Keep Out of Reach of Children
Ask a doctor before us if you have:
- Kidney disease
- Stomach pain, nausea or vomiting
- A magnesium restricted diet
- A sudden change in bowel habits that lasts over 14 days
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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 one week.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
This package bears a tamper evident seal. If the seal is broken, do not use.
- Suggested Uses
- Shake well before use – Do not dilute.
- 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
10 to 20 mL (2 to 4 tsp.)
Children 6 to 11 Years
5 to 10 mL (1 to 2 tsp.)
Children under 6 Years
Ask a Doctor
- Other Information
- Storage and Handling
- Inactive Ingredients
- Questions or Comments?
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
MILK OF MAGNESIA
milk of magnesia concentrate
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0054-3567 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg in 10 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) LEMON OIL (UNII: I9GRO824LL) WATER (UNII: 059QF0KO0R) SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) VANILLIN (UNII: CHI530446X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0054-3567-49 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2001 2 NDC:0054-3567-61 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/12/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/12/2001 Labeler - West-Ward Pharmaceuticals Corp. (080189610) Registrant - Roxane Laboratories, Inc. (833490464) Establishment Name Address ID/FEI Business Operations West-Ward Columbus Inc. 058839929 MANUFACTURE(0054-3567)