Hydroxyurea (Page 4 of 4)

17 PATIENT COUNSELING INFORMATION

There is a risk of myelosuppression. Monitoring blood counts weekly throughout the duration of therapy should be emphasized to patients taking hydroxyurea capsules [see Warnings and Precautions (5.1)]. Advise patients to report signs and symptoms of infection or bleeding immediately.
Advise patients that there is a risk of cutaneous vasculitic toxicities and secondary malignancies including leukemia and skin cancers [see Warnings and Precautions (5.2, 5.4)].
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females and males of reproductive potential to use contraception during and after treatment with hydroxyurea capsules [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1,8.3)].
Advise patients to inform their healthcare provider if they have received or are planning to receive vaccinations while taking hydroxyurea capsules as this may result in a severe infection [see Warnings and Precautions (5.5) ].
Advise females to discontinue breastfeeding during treatment with hydroxyurea capsules [see Use in Specific Populations (8.2)].
Patients with HIV infection should contact their physician for signs and symptoms of pancreatitis, hepatic events, and peripheral neuropathy [see Warnings and Precautions (5.6)].
Post-irradiation erythema can occur in patients who have received previous irradiation therapy [see Warnings and Precautions (5.7)].
Advise patients of the symptoms of potential pulmonary toxicity and instruct them to seek prompt medical attention in the event of pyrexia, cough, dyspnea, or other respiratory symptoms [see Warnings and Precautions (5.9)].

For more information, go to www.parpharm.com or call 1-800-828-9393.

Manufactured by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

Packaged and Distributed By:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268 USA

Refer to package label for Distributor’s NDC Number

Issued: 06/2021

Package/Label Display Panel

Hydroxyurea Capsules, USP

500 mg

100 Capsules

carton label
(click image for full-size original)
HYDROXYUREA
hydroxyurea capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6939(NDC:49884-724)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYUREA (HYDROXYUREA) HYDROXYUREA 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (Dark Green) , PINK (Pink) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 724;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6939-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-6939-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075340 02/24/1999
Labeler — Major Pharmaceuticals (191427277)

Revised: 08/2023 Major Pharmaceuticals

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