FDA.reportPublic FDA data

Anti-Empacho

Manufacturer
Menper Distributors, Inc. | Rnv LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:08:17

Label at a glance#

ProductAnti-Empacho
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Indications and uses

For The relieve of:    heartburn acid indigestion sour stomach       upset stomach due to these symptoms

Dosage and administration

Adults and children 12 years of age and older ...................................1 tablespoonful 2 or 3 times a day Children under 12 years of age .........................................................Consult a physician 

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (In each tablespoonful 15ml)

Sodium Bicarbonate 525 mg. (6.25 mEq)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

For The relieve of:   

  • heartburn
  • acid indigestion
  • sour stomach      
  • upset stomach due to these symptoms

Ask a doctor or pharmacist before using if you are

WARNINGS SECTION

  • presently taking a prescription drug .Antacids may interact with certain prescription drugs
  • experiencing abdominal pain, nausea or other symptoms of appendicitis
  • on a sodium-restricted diet

WARNINGS SECTION

Do not take more than the maximum recomended daily dosage in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

If pregnant or breastfeeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before using this product.

Keep out reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediatly.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older ...................................1 tablespoonful 2 or 3 times a day

Children under 12 years of age .........................................................Consult a physician 

Other information 

OTHER SAFETY INFORMATION

  • each 15 mL contains =: sodium 144 mg 
  • store this product between 15° to 30° C (59° to 86° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, methylparaben, peppermint spirit, propylene glycol, propylparaben, rhubarb FE, water

Questions?

OTC - QUESTIONS SECTION

1-800-560-5223 M-F from 9 AM to 4 PM Eastern

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305093sodium bicarbonate 525 MG in 15 mL Oral SolutionPSN9
1305093sodium bicarbonate 0.417 MEQ/ML Oral SolutionSCD9
1305093NaHCO3 0.417 MEQ/ML Oral SolutionSY9
1305093sodium bicarbonate 525 MG per 15 ML Oral SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-300-082023-07-28C16284748780-19d75b9cf-e726-f424-e053-dadaa90a57ceAnti-Empacho
53145-300-082022-02-18C16284748780-19d75b9cf-e726-f424-e053-dadaa90a57ceAnti-Empacho
53145-300-082022-01-28C16284748780-19d75b9cf-e726-f424-e053-dadaa90a57ceAnti-Empacho
53145-300-082020-02-04C16284748780-19d75b9cf-e726-f424-e053-dadaa90a57ceAnti-Empacho
53145-300-082020-01-31C16284748780-19d75b9cf-e726-f424-e053-dadaa90a57ceAnti-Empacho

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-300-08Anti-Empacho240 mL in 1 BOTTLELIQUID2409
53145-300-08Anti-Empacho1 in 1 CARTONLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO4
SODIUM CATIONACTIVE MOIETYLYR4M0NH374
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
IPECACINACTIVE INGREDIENT62I3C8233L4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2B4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
RHUBARBINACTIVE INGREDIENTG280W4MW6E4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-30053145-300-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
PEPPERMINTV95R5KMY2BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
RHUBARBG280W4MW6EIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
ndc (package): 53145-300-08
ndc (product): 53145-300
ndc11 (package): 53145030008
spl id: 3a8a758e-b2f8-c7ad-e063-6294a90ad6e9
spl set id: 43807221-58f0-434d-be2d-fa0f54b95db8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.