LANOXIN (Page 8 of 8)

17 PATIENT COUNSELING INFORMATION

Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of LANOXIN may be too high.
Advise parents or caregivers that the symptoms of having too high LANOXIN doses may be difficult to recognize in infants and pediatric patients. Symptoms such as weight loss, failure to thrive in infants, abdominal pain, and behavioral disturbances may be indications of digoxin toxicity.
Instruct the patient to monitor and record their heart rate and blood pressure daily.

LANOXIN is registered trademark of GlaxoSmithKline.

Covis Logo

Manufactured for
Covis PharmaZug, 6300 Switzerland

2020, Covis Pharma. All rights reserved.

PRINCIPAL DISPLAY PANEL — Adult Carton Label — Ampule

Principal Display Panel -- Adult Carton Label -- Ampule
(click image for full-size original)

Adult Carton Label — Ampule

C O V I S

10 ampuls 2 mL each NDC 70515-260-10

LANOXIN® (digoxin) Injection

500 mcg (0.5 mg) in 2 mL
(250 mcg [0.25 mg] per mL)

A sterile solution for intravenous or intramuscular injection. Dilution not required.

In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V).
Dibasic sodium phosphate 0.17%, citric acid anhydrous 0.08%.

See prescribing information for dosage information.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP
Controlled Room Temperature] and protect from light.

Rx only

Manufactured for
Covis Pharma
Zug, 6300 Switzerland
Made in Germany©2017, Covis Pharma

PRINCIPAL DISPLAY PANEL — Adult Carton Label — Vial

Principal Display Panel -- Adult Carton Label -- Vial
(click image for full-size original)

Adult Carton Label — Vial

C O V I S

NDC 70515-261-10 10 vials 2 mL each

LANOXIN® (digoxin) Injection

500 mcg (0.5 mg) in 2 mL
(250 mcg [0.25 mg] per mL).

Rx only

NDC 70515-261-10
LANOXIN® (digoxin) Injection 500 mcg (0.5 mg) in 2 mL (250 mcg [0.25 mg] per mL)

A sterile solution for intravenous or intramuscular injection. Dilution
not required.

In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V).
Dibasic sodium phosphate 0.17%, citric acid anhydrous 0.08%.

See prescribing information for dosage information.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)
[see USP Controlled Room Temperature] and protect from light.

GTIN
S/N

EXP MMM YYYY
LOT

Manufactured for
Covis Pharma
Zug, 6300 Switzerland

Made in Germany©2019, Covis Pharma

PRINCIPAL DISPLAY PANEL — Pediatric Carton Label — Ampule

Principal Display Panel -- Pediatric Carton Label -- Ampule
(click image for full-size original)

Pediatric Carton Label — Ampule

NDC 70515-262-10 10 ampuls 1 mL each

LANOXIN® (digoxin) Injection
Pediatric

100 mcg (0.1 mg) in 1 mL

A sterile solution for intravenous or intramuscular injection. Dilution not required. In a vehicle of
42.5% (W/V) propylene glycol and 10% alcohol (V/V). Sodium phosphate 0.17%. Citric acid anhydrous 0.08%.

See prescribing information for dosage information.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] and protect from light.

Rx only C O V I S

PRINCIPAL DISPLAY PANEL — Pediatric Carton Label — Vial

Principal Display Panel -- Pediatric Carton Label -- Vial
(click image for full-size original)

Pediatric Carton label — Vial

NDC 70515-263-10 10 vials 1 mL each Rx only

LANOXIN® (digoxin) Injection
Pediatric

100 mcg (0.1 mg) in 1 mL

C O V I S

NDC 70515-263-10 10 vials 1 mL each

LANOXIN® (digoxin) Injection Pediatric
100 mcg (0.1 mg) in 1 mL

A sterile solution for intravenous or intramuscular injection. Dilution
not required. In a vehicle of 42.5% (W/V) propylene glycol and 10% alcohol (V/V).
Sodium phosphate 0.17%. Citric acid anhydrous 0.08%.

See prescribing information for dosage information.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F)
[see USP Controlled Room Temperature] and protect from light.

GTIN
S/N

EXP MMM YYYY
LOT

Manufactured for
Covis Pharma
Zug, 6300 Switzerland

Made in Germany©2019, Covis Pharma

LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-260
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-260-10 10 AMPULE in 1 BOX contains a AMPULE
1 2 mL in 1 AMPULE This package is contained within the BOX (70515-260-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 09/15/2017
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-261
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 250 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-261-10 10 VIAL in 1 BOX contains a VIAL
1 2 mL in 1 VIAL This package is contained within the BOX (70515-261-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 10/29/2019
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-262
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-262-10 10 AMPULE in 1 BOX contains a AMPULE
1 1 mL in 1 AMPULE This package is contained within the BOX (70515-262-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 09/15/2017
LANOXIN digoxin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70515-263
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 100 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
ANHYDROUS CITRIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70515-263-10 10 VIAL in 1 BOX contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BOX (70515-263-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009330 10/29/2019
Labeler — Covis Pharma (486209070)

Revised: 10/2020 Covis Pharma

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