FLANAX ANTACID- aluminum hydroxide, magnesium hydroxide and dimethicone liquid 
Belmora 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.

----------

Flanax® Antacid

Drug Facts

Active ingredients
(in each 5 ml) (One teaspoonful)		Purpose
Aluminum Hydroxide
(Equi. to Dried Gel, USP) 200 mg		Antacid
Magnesium Hydroxide 200 mgAntacid
Simethicone 20 mgAntigas

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • associated symptoms of gas and upset stomach
  • overindulgence
  • of food and drink

Warnings

Ask a doctor before use if you have kidney disease

  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

If pregnant or breast-feading, ask a health professional before use.

Stop use and ask a doctor if

  • symptoms last more than 2 weeks

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • shake well before each use
  • Adults/ children 12 years and older take 2 to 4 teaspoons four times a day or as directed by a physician
  • do not take more than 12 teaspoonsful in 24 hours or use the maximum dosage for more than 2 weeks
  • Children under 12 years: consult a physician

Other information

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

  • store at room temperature 15°-30°C (59°-86°F)
  • keep tightly closed
  • protect from freezing
  • each teaspoon (5 mL) contains: magnesium 83 mg
  • each teaspoon (5 mL) contains: sodium 1 mg

Inactive ingredients

flavors, hypromellose, parabens, sodium hypochlorite, saccharin, sorbitol, xanthan gum and water.

Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

NDC 27854.101.01

REV 09/2012

Belmora LLC

FLANAX®

FAST ACTING ANTACID

Heartburn Relief

12

FL OZ
(355 ML)

NEUTRAL FLAVOR

Principal Display Panel - 355 mL Bottle Label
FLANAX ANTACID 
aluminum hydroxide, magnesium hydroxide, and dimethicone liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:27854-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (Aluminum Hydroxide) ALUMINUM HYDROXIDE14.2 g  in 355 mL
MAGNESIUM HYDROXIDE (Magnesium Cation) MAGNESIUM HYDROXIDE14.2 g  in 355 mL
DIMETHICONE (Dimethicone) DIMETHICONE1.4 g  in 355 mL
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSE 2910 (4000 MPA.S) 
GLYCERIN 
PROPYLENE GLYCOL 
SORBITOL 
BUTYLPARABEN 
PROPYLPARABEN 
SACCHARIN SODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-101-01355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/06/2012
Labeler - Belmora LLC (112753244)
Registrant - RIJ Pharmaceutical Corp (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Integrated Pharma Solutions049528220MANUFACTURE(27854-101)

Revised: 8/2014
Document Id: 09749fda-0b18-4291-ba7b-93bdc730e6ba
Set id: 5a884039-89a3-4c24-b399-f7369628be17
Version: 7
Effective Time: 20140812
 
Belmora LLC