Potassium Chloride

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2025-09-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:41:53

Key Label Information#

Uses

1 INDICATIONS AND USAGE

Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on triamterene and amiloride.

Warnings

4 CONTRAINDICATIONS

Potassium chloride is contraindicated in patients on triamterene and amiloride.

5 WARNINGS AND PRECAUTIONS

Directions And Dosage

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

Potassium Chloride Extended-Release Tablets, USP are supplied as: The 8 mEq (600 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “106” on one side, and “8” on the other side. The 10 mEq (750 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “105” on one side, and “10” on the other side.

10 OVERDOSAGE

Other Label Information

16 HOW SUPPLIED/STORAGE AND HANDLING

Potassium Chloride Extended-Release Tablets, USP contain 600 mg or 750 mg of Potassium Chloride, USP (equivalent to 8 mEq and 10 mEq respectively), and are provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 tablets Bottle of 500 tablets Bottle of 1000 tablets 600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side 42806-422-01 42806-422-05 42806-422-10 750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-01 42806-423-05 42806-423-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight container as defined in the USP with a child-resistant closure.

PRINCIPAL DISPLAY PANEL - 10mEq (750mg)

NDC 71610-945 - Potassium Chloride ER, USP 10mEq (750mg) Tablets - Rx Only

Label Images#

Aphena
Aphena
71610-0945-30
71610-0945-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN1
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD1
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY1
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY1
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY1
628953potassium chloride 750 MG Extended Release Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
POTASSIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-945-30Potassium Chloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
71610-945-53Potassium Chloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601
71610-945-60Potassium Chloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71610-945-70Potassium Chloride120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-945-30EA - Each71610-945e9b857c0-c24b-4938-84e3-dc6300ef2e3512025-10-14
71610-945-53EA - Each71610-945c0d915ff-f55e-4788-953b-71e47ee90de412025-10-14
71610-945-60EA - Each71610-945660e57d9-dffa-4286-9d1c-e9f41d4bed7712025-10-14
71610-945-70EA - Each71610-945732aa1bb-d351-413f-a35d-b2c94fa7cdc312025-10-14
42806-423-01EA - Each42806-4238594d722-482d-45e7-bb33-4174063230db12023-09-05
42806-423-05EA - Each42806-423893dd363-a943-4dbd-ba44-06b43712428b12023-09-05
42806-423-10EA - Each42806-4239a17180f-7ddc-4f8d-a663-6709fd2fb16912023-09-05

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-94571610-945-30, 71610-945-53, 71610-945-60, 71610-945-70
42806-423

Ingredients#

Complete SPL Sections#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Potassium Chloride Extended-Release Tablets, USP are supplied as: The 8 mEq (600 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “106” on one side, and “8” on the other side. The 10 mEq (750 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “105” on one side, and “10” on the other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Potassium chloride is contraindicated in patients on triamterene and amiloride.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

11 DESCRIPTION

DESCRIPTION SECTION

Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Potassium Chloride Extended-Release Tablets, USP contain 600 mg or 750 mg of Potassium Chloride, USP (equivalent to 8 mEq and 10 mEq respectively), and are provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 tablets Bottle of 500 tablets Bottle of 1000 tablets 600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side 42806-422-01 42806-422-05 42806-422-10 750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-01 42806-423-05 42806-423-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight container as defined in the USP with a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed.

REPACKAGING INFORMATION

SPL UNCLASSIFIED SECTION

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 10mEq (750mg) NDC 71610-945-30, Bottles of 30 Tablets NDC 71610-945-53, Bottles of 60 Tablets NDC 71610-945-60, Bottles of 90 Tablets NDC 71610-945-70, Bottles of 120 Tablets Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20250904AMH

PRINCIPAL DISPLAY PANEL - 10mEq (750mg)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-945 - Potassium Chloride ER, USP 10mEq (750mg) Tablets - Rx Only

Source Document#

Source XML