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FLANAX Antacid Anti-gas

Medically reviewed on Dec 19, 2017

Dosage form: liquid
Ingredients: ALUMINUM HYDROXIDE 200mg in 5mL, MAGNESIUM HYDROXIDE 200mg in 5mL, SIMETHICONE 20mg in 5mL
Labeler: Belmora LLC
NDC Code: 27854-112

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 ANTI-GAS

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

Purpose

Antacid

Antacid

Antigas

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 • magnesium-restricted diet

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

Stop use and ask a doctor if symptoms last more than 2 weeks

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

Keep out of reach of children.

Directions   • shake well before each use   

• adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

• do not take more than 24 teaspoonsfuls in 24 hours or use the maximum dosage for more than 2 weeks  

• children under 12: ask a doctor

Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Other informationeach 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg • store at room temperature • protect from freezing • keep tightly closed

Questions or comments? 1-888-779-2877

Heartburn Relief

ORIGINAL FLAVOR

Alcohol: Less than 0.5%

TAMPER EVIDENT: Do not use in breakaway band on cap is broken or missing.

Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203 www.flanax.com

Packaging

FLANAX ANTACID ANTI-GAS 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE200 mg  in 5 mL
MAGNESIUM HYDROXIDE (MAGNESIUM CATION) MAGNESIUM HYDROXIDE200 mg  in 5 mL
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
HYPROMELLOSE, UNSPECIFIED 
MICROCRYSTALLINE CELLULOSE 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (lemon) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:27854-112-01355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/30/2016
Labeler - Belmora LLC (112753244)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP Laboratories965480861manufacture(27854-112), pack(27854-112)

 
Belmora LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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