Effer-K Unflavored (Page 2 of 2)

Labor and Delivery

Information unknown.

Nursing Mothers

Although no studies have been done, it is presumed that potassium is excreted in human milk. Caution should be exercised when Effer-K® 25mEq TABLETS (Potassium Bicarbonate Effervescent Tablets for Oral Solution, USP) are administered to a nursing woman.

Usage in Children

Safety and effectiveness in children have not been established.

Adverse Reactions to Effer-K Unflavored

One of the most severe adverse effects is hyperkalemia (see Contraindications, Warnings and Overdosage). The most common adverse reactions to oral potassium salts are nausea, vomiting, abdominal discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals, or reducing the dose. Skin rash has been reported rarely.

Overdosage

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see Contraindications and Warnings). It is important to recognize that initally hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment, and prolongation of the QT interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.

Treatment measures for hyperkalemia include the elimination of foods and medications containing potassium and potassium-sparing diuretics, as well as ACE inhibitors, beta blocking agents, NSAIDs, heparin, and cyclosporine. In cases of life-threatening hyperkalemia, treatment measures may include: (1) intravenous administration of 300 to 500 ml/hr of 10% dextrose solution containing 10-20 units of insulin per 1,000 ml; (2) correction of acidosis, if present, with intravenous sodium bicarbonate; (3) use of exchange resins, hemodialysis, or peritoneal dialysis; (4) administration of a calcium salt to antagonize the cardiotoxic effects in patients whose electrocardiograms show appropriate characteristics, and who are not receiving digitalis glycosides; and (5) maintenance of a high urine output in suitable patients.

In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, rapid lowering of serum potassium can produce digitalis toxicity.

Dosage and administration

Dosage and Administration: Adults- One Effer-K® flavored tablet, (Orange, Lemon Citrus or Cherry Berry) each containing 25 mEq (978 mg) of potassium, completely dissolved in 4 ounces of cold or ice water, 1 to 4 times daily, depending on the requirement of the patient. For Effer-K® unflavored tablets (each containing 25 mEq (978 mg) of potassium) we recommend completely dissolving one tablet in 12 to 16 ounces of cold juice of the patient’s choice.

NOTE: It is suggested that any effervescent potassium tablets be taken with meals and sipped slowly over a 5 to 10 minute period.

How Supplied

Effer-K® 25 mEq TABLETS (Potassium Bicarbonate Effervescent Tablets for Oral Solution, USP). Each tablet in solution provides 25 mEq of elemental potassium as potassium citrate. Store below 40˚C (104˚F) preferably between 15˚ and 30˚C (59˚ and 86˚F), in original hermetic packaging.

Tablets are one inch diameter round, flat face on both sides with large bevels. “EK 25” is imprinted one side of the tablets. Each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date, and barcode on the other.

NDC 51801-001-30 Orange-flavored, package of 30 tablets. NDC 51801-005-30 Lemon Citrus-flavored, package of 30 tablets.
NDC 51801-001-40 Orange-flavored, package of 100 tablets. NDC 51801-006-30 Cherry Berry-flavored, package of 30 tablets.
NDC 51801-007-30 Unflavored, package of 30 tablets.

Nomax, Inc. St. Louis, MO 63123 — Made in USA
MSN 015-031

Rev. 08/10

PRINCIPAL DISPLAY PANEL — 30 Tablet Pouch Carton — Unflavored

NDC 51801-007-30
30 Tablets

Effer-K® 25 mEq Tablets

POTASSIUM BICARBONATE EFFERVESCENT TABLETS
FOR ORAL SOLUTION, USP

Each Tablet contains 25mEq (978 mg) of Potassium

Unflavored (Dissolve in 12-16 ounces of juice) Rx Only

nomax inc

PRINCIPAL DISPLAY PANEL -- 30 Tablet Pouch Carton -- Unflavored
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Pouch Carton — Orange

NDC 51801-001-30
30 Tablets

Effer-K® 25 mEq Tablets

POTASSIUM BICARBONATE EFFERVESCENT TABLETS
FOR ORAL SOLUTION, USP

Each Tablet contains 25mEq (978 mg) of Potassium

Orange Flavored Rx Only

nomax inc

PRINCIPAL DISPLAY PANEL -- 30 Tablet Pouch Carton -- Orange
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Pouch Carton — Lemon

NDC 51801-005-30
30 Tablets

Effer-K® 25 mEq Tablets

POTASSIUM BICARBONATE EFFERVESCENT TABLETS
FOR ORAL SOLUTION, USP

Each Tablet contains 25mEq (978 mg) of Potassium

Lemon Citrus Flavored Rx Only

nomax inc

PRINCIPAL DISPLAY PANEL -- 30 Tablet Pouch Carton -- Lemon
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Pouch Carton — Cherry

NDC 51801-006-30
30 Tablets

Effer-K® 25 mEq Tablets

POTASSIUM BICARBONATE EFFERVESCENT TABLETS
FOR ORAL SOLUTION, USP

Each Tablet contains 25mEq (978 mg) of Potassium

Cherry Berry Flavored Rx Only

nomax inc

PRINCIPAL DISPLAY PANEL -- 30 Tablet Pouch Carton -- Cherry
(click image for full-size original)

EFFER-K UNFLAVORED potassium bicarbonate tablet, effervescent
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-007
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM BICARBONATE (BICARBONATE ION) POTASSIUM BICARBONATE 977.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 2100 mg
MINERAL OIL 34 mg
TALC 20 mg
CELLULOSE, MICROCRYSTALLINE 100 mg
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 25mm
Flavor Imprint Code EK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51801-007-30 30 POUCH in 1 CARTON contains a POUCH
1 1 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (51801-007-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/30/2013
EFFER-K ORANGE potassium bicarbonate tablet, effervescent
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM BICARBONATE (BICARBONATE ION) POTASSIUM BICARBONATE 977.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 2100 mg
MINERAL OIL 34 mg
TALC 20 mg
CELLULOSE, MICROCRYSTALLINE 100 mg
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 25mm
Flavor ORANGE Imprint Code EK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51801-001-30 30 POUCH in 1 CARTON contains a POUCH
1 1 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (51801-001-30)
2 NDC:51801-001-40 100 POUCH in 1 CARTON contains a POUCH
2 1 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (51801-001-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/30/2013
EFFER-K LEMON CITRUS potassium bicarbonate tablet, effervescent
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM BICARBONATE (BICARBONATE ION) POTASSIUM BICARBONATE 977.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 2100 mg
MINERAL OIL 34 mg
TALC 20 mg
CELLULOSE, MICROCRYSTALLINE 100 mg
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 25mm
Flavor LEMON (Lemon Citrus) Imprint Code EK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51801-005-30 30 POUCH in 1 CARTON contains a POUCH
1 1 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (51801-005-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/30/2013
EFFER-K CHERRY BERRY potassium bicarbonate tablet, effervescent
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51801-006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM BICARBONATE (BICARBONATE ION) POTASSIUM BICARBONATE 977.5 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 2100 mg
MINERAL OIL 34 mg
TALC 20 mg
CELLULOSE, MICROCRYSTALLINE 100 mg
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 25mm
Flavor CHERRY (Cherry Berry) Imprint Code EK;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51801-006-30 30 POUCH in 1 CARTON contains a POUCH
1 1 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (51801-006-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/30/2013
Labeler — Nomax Inc. (103220273)
Establishment
Name Address ID/FEI Operations
Nomax Inc. 103220273 MANUFACTURE (51801-007) (51801-001) (51801-005) (51801-006)

Revised: 12/2019 Nomax Inc.

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