Drug Labeling and Warnings

Drug Details

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MILK OF MAGNESIA - magnesium hydroxide liquid 
Better Living Brands, LLC

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.

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Drug Facts

Active ingredient (in each 15 mL Tablespoon)

Magnesium hydroxide USP 1200 mg

Purpose

Saline laxative

Use

relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ 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

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • 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.
  • for accurate dosing, only use the dosing cup provided
  • do not use any other dosing device
  • TBSP = Tablespoon, mL = milliliter

age
dose
adults and children 12 years and older
30 mL (2 TBSP) to 60 mL (4 TBSP)
children 6 to 11 years
15 mL (1 TBSP) to 30 mL (2 TBSP)
children under 6 years
ask a doctor

Other information

  • each tablespoon (15 mL) contains : calcium 20 mg and magnesium 495 mg
  • store at 20-25°C (68-77°F).  Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.

Inactive ingredients

flavor, purified water, saccharin sodium

Questions or comments?

1-888-723-3929

* This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Phillips’® Milk of Magnesia.

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

COMPARE TO Phillips’® Milk of Magnesia active ingredient*
NDC: 21130-994-16
Signature CareTM
Quality Guaranteed
Milk of Magnesia
SALINE LAXATIVE
Each 15 mL (1TBSP) dose of oral solution contains: 1200 mg - Magnesium hydroxide USP
MINT FLAVOR
NATURALLY FLAVORED

  • Stimulant free
  • Comfortable, cramp free relief
  • Sugar free
TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

12 FL OZ (355 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

MILK OF MAGNESIA 
magnesium hydroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 21130-994
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
PEPPERMINT (UNII: V95R5KMY2B)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITE (White to off-white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 21130-994-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product02/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/04/2016
Labeler - Better Living Brands, LLC (009137209)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(21130-994)

Revised: 6/2016
 
Better Living Brands, LLC


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