FDA.reportPublic FDA data

AQUACID-200

Manufacturer
Aqua Medica, S.A. de C.V.
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:43:12

Label at a glance#

ProductAQUACID-200
Active ingredientPOTASSIUM CHLORATE
Label structure14 sections

Dosage and administration

By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Storage and handling

Store at room temperature. Keep container tightly closed when not in use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a Hemodialysis Acid Concentrate, Pyrogen-Free.

By diluiting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:

Sodium: 100.00 mEq/l

Potassium: 0.00 mEq/l

Calcium: 3.00 mEq/l

Magnesium: 0.75 mEq/l

Chlorides: 103.75 mEq/l

Acetate: 4.00 mEq/l

Dextrose: 100.00 mEq/l

The final conductivity calculated at 25 C is 13.2 to 14.2 mS/cm.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Potassium Chloride

Purpose

OTC - PURPOSE SECTION

For use with 3-pump hemodialysis machines only.

Use

INDICATIONS & USAGE SECTION

For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

Warnings

WARNINGS SECTION

For use with 3-pump hemodialysis machines only.

Do not use

OTC - DO NOT USE SECTION

  • If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.

OTC - WHEN USING SECTION

Using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

If you do not use the entire contents, discard the excess.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature.
  • Keep container tightly closed when not in use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium chloride, calcium chloride, acetic acid, dextrose, purified water USP

RECENT MAJOR CHANGES SECTION

For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.

By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL Label3785 mL Label3785 mL NDC: 81943-603-03

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product 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
81943-603-032024-11-18C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3
81943-603-032024-11-18C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3
81943-603-032024-07-30C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3
81943-603-032024-07-30C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3
81943-603-032024-01-30C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3
81943-603-032024-01-30C16284748780-11030e365-1d8c-111a-e063-dadaa90a10e2c3cd1703-ced5-114a-e053-2995a90a4db3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81943-603-03AQUACID-2003785 mL in 1 BOTTLESOLUTION, CONCENTRATE37857

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
81943-60381943-603-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
ACETIC ACID C-112A9OM7IPNWIACT
DEXTROSEIY9XDZ35W2IACT
WATER059QF0KO0RIACT
POTASSIUM CHLORATEH35KS68EE7ACTIB
MAGNESIUM CHLORIDE02F3473H9OIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-18full-release2026-06-01 00:37:51

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
AQUACID-200ACID CONCENTRATE FOR HEMODIALYSISAqua Medica, S.A. de C.V.c3cd1703-ced5-114a-e053-2995a90a4db32025-11-10WarningsExact identifier
ndc (package): 81943-603-03
ndc (product): 81943-603
ndc11 (package): 81943060303
spl id: 43487368-cb5e-8eda-e063-6294a90a705e
spl set id: c3cd1703-ced5-114a-e053-2995a90a4db3

Reported adverse events (FAERS/openFDA)#

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