Dosage and administration
By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
AQUACID-100
- Manufacturer
- Aqua Medica, S.A. de C.V.
- Effective date
- 2025-11-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:43:11
Label at a glance#
ProductAQUACID-100
Active ingredientPOTASSIUM CHLORATE
Label structure14 sections
Storage and handling
Store at room temperature.
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: 2.00 mEq/l
Calcium: 3.00 mEq/l
Magnesium: 0.75 mEq/l
Chlorides: 105.75 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)
Potassium Chloride
Purpose
For use with 3-pump hemodialysis machines only.
Use
For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
Warnings
For use with 3-pump hemodialysis machines only.
Do not use
- 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
- By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
Other information
- Store at room temperature.
Inactive ingredients
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 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2 | Product name | 5 | 20250304 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 87711080-88eb-65c5-b2dd-bf99e700a372 | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81943-605-01 | 2024-11-18 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
| 81943-605-01 | 2024-11-18 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
| 81943-605-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
| 81943-605-01 | 2024-07-30 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
| 81943-605-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
| 81943-605-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0962-111a-e063-dadaa90a10e2 | c3c087ef-0efd-2ef8-e053-2995a90af189 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81943-605-01 | AQUACID-100 | 3785 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 3785 | 8 |
Products#
Every source-derived product name is available through these pages.
- AQUACID-100
- Acid Concentrate for Hemodialysis
- MAGNESIUM CHLORIDE
- ACETIC ACID C-11
- POTASSIUM CHLORATE
- CHLORATE ION
- CALCIUM CHLORIDE
- WATER
- SODIUM CHLORIDE
- DEXTROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81943-605 | 81943-605-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM CHLORIDE | 02F3473H9O | IACT |
| ACETIC ACID C-11 | 2A9OM7IPNW | IACT |
| POTASSIUM CHLORATE | H35KS68EE7 | ACTIB |
| CALCIUM CHLORIDE | M4I0D6VV5M | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2024-11-18 | full-release | 2026-06-01 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AQUACID-100 | ACID CONCENTRATE FOR HEMODIALYSIS | Aqua Medica, S.A. de C.V. | c3c087ef-0efd-2ef8-e053-2995a90af189 | 2025-11-10 | Warnings | 81943-605-01 81943-605 81943060501 43485fab-fcf3-6ef5-e063-6294a90a52bb c3c087ef-0efd-2ef8-e053-2995a90af189 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.