ENO- aluminum hydroxide, magnesium hydroxide, simethicone solution 
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.

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Active Ingredients

(in each 5 ml) (one teaspoonful)                                       Purpose

Aluminum Hydroxide

(Equi. to Dried Gel, USP) 200 mg ............................................. Antiacid

Magnesium Hydroxide 200 mg ................................................. Antiacid

Simethicone 20 mg .................................................................. Antigas

Uses

relieves

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

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

ENO Heartburn Relief Alivia La Acidez

Antiacido Liquido Liquid Antacid

12 Fl Oz (355 ML) | Sabor Neutral Neutral Flavor

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 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
  • Children under 12 years: consult a physician

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-retricted 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-feeding, ask a health professional before use.

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

Inactive Ingredients

avicel RC591 (NaCMC/MCC), butylparaben, flavor, glycerin, methocel E4M, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol.

Other information:

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

  • does not meet USP requirements for preservative effectiveness
  • 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
Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203

Packaging

ENO1

ENO 
aluminum hydroxide, magnesium hydroxide, simethicone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 g
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE200 mg  in 5 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 g
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-104-01355 g in 1 BOTTLE; Type 0: Not a Combination Product03/12/201506/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33103/12/201506/30/2017
Labeler - Belmora LLC (112753244)
Establishment
NameAddressID/FEIBusiness Operations
Integrated Pharma Solutions049528220manufacture(27854-104)

Revised: 8/2016
 
Belmora LLC