Levothyroxine Sodium: Package Insert and Label Information (Page 4 of 5)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies to evaluate mutagenic potential and animal fertility have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Levothyroxine sodium tablets, USP are flat, beveled edge capsule shaped scored tablets and are supplied as follows (Table 11):

Table 11: Levothyroxine Sodium Tablets, USP Presentations

Strength

Color/Shape

Debossed Tablet Markings

NDC # for bottles of 90

NDC # for bottles of 100

NDC # for bottles of 1000

25 mcg

Orange/ Capsule Shaped

25 on the unscored side and T bisect V on the scored side, with side scores

0480-8682-98

0480-8682-01

0480-8682-10

50 mcg

White/ Capsule Shaped

50 on the unscored side and T bisect V on the scored side, with side scores

0480-8687-98

0480-8687-01

0480-8687-10

75 mcg

Violet/ Capsule Shaped

75 on the unscored side and T bisect V on the scored side, with side scores

0480-8690-98

0480-8690-01

0480-8690-10

88 mcg

Olive/ Capsule Shaped

88 on the unscored side and T bisect V on the scored side, with side scores

0480-8693-98

0480-8693-01

0480-8693-10

100 mcg

Yellow/ Capsule Shaped

100 on the unscored side and T bisect V on the scored side, with side scores

0480-8701-98

0480-8701-01

0480-8701-10

112 mcg

Rose/ Capsule Shaped

112 on the unscored side and T bisect V on the scored side, with side scores

0480-8704-98

0480-8704-01

0480-8704-10

125 mcg

Brown/ Capsule Shaped

125 on the unscored side and T bisect V on the scored side, with side scores

0480-8707-98

0480-8707-01

0480-8707-10

137 mcg

Turquoise/ Capsule Shaped

137 on the unscored side and T bisect V on the scored side, with side scores

0480-8710-98

0480-8710-01

0480-8710-10

150 mcg

Blue/ Capsule Shaped

150 on the unscored side and T bisect V on the scored side, with side scores

0480-8715-98

0480-8715-01

0480-8715-10

175 mcg

Lilac/ Capsule Shaped

175 on the unscored side and T bisect V on the scored side, with side scores

0480-8718-98

0480-8718-01

0480-8718-10

200 mcg

Pink/ Capsule Shaped

200 on the unscored side and T bisect V on the scored side, with side scores

0480-8722-98

0480-8722-01

0480-8722-10

300 mcg

Green/ Capsule Shaped

300 on the unscored side and T bisect V on the scored side, with side scores

0480-8725-98

0480-8725-01

0480-8725-10

Storage and Handling

Store at 25°C (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, light-resistant container as defined in the USP.

17 PATIENT COUNSELING INFORMATION

Inform the patient of the following information to aid in the safe and effective use of levothyroxine sodium tablets:

Dosing and Administration

  • Instruct patients to take levothyroxine sodium tablets only as directed by their healthcare provider.
  • Instruct patients to take levothyroxine sodium tablets as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
  • Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take levothyroxine sodium tablets within 4 hours of these agents.
  • Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking levothyroxine sodium tablets.

Important Information

  • Inform patients that it may take several weeks before they notice an improvement in symptoms.
  • Inform patients that the levothyroxine in levothyroxine sodium tablets is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
  • Inform patients that levothyroxine sodium tablets should not be used as a primary or adjunctive therapy in a weight control program.
  • Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.
  • Instruct patients to notify their physician of any other medical conditions they may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while they are taking levothyroxine sodium tablets. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.
  • Instruct patients to notify their physician or dentist that they are taking levothyroxine sodium tablets prior to any surgery.

Adverse Reactions

  • Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.
  • Inform patients that partial hair loss may occur rarely during the first few months of levothyroxine sodium tablet therapy, but this is usually temporary.

Manufactured in Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals Parsippany, NJ 07054 USA

Rev. A 9/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8682-98

Levothyroxine Sodium Tablets, USP

25 mcg (0.025 mg)

Rx only

90 Tablets

Label 25 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8687-98

Levothyroxine Sodium Tablets, USP

50 mcg (0.05 mg)

Rx only

90 Tablets

Label 50 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8690-98

Levothyroxine Sodium Tablets, USP

75 mcg (0.075 mg)

Rx only

90 Tablets

Label 75 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8693-98

Levothyroxine Sodium Tablets, USP

88 mcg (0.088 mg)

Rx only

90 Tablets

Label 88 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8701-98

Levothyroxine Sodium Tablets, USP

100 mcg (0.1 mg)

Rx only

90 Tablets

Label 100 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8704-98

Levothyroxine Sodium Tablets, USP

112 mcg (0.112 mg)

Rx only

90 Tablets

Label 112 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8707-98

Levothyroxine Sodium Tablets, USP

125 mcg (0.125 mg)

Rx only

90 Tablets

Label 125 mcg, 90 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-8710-98

Levothyroxine Sodium Tablets, USP

137 mcg (0.137 mg)

Rx only

90 Tablets

Label 137 mcg, 90 Tablets
(click image for full-size original)

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