Each sustained release Kronofed A®, white and clear capsule contains:

Each sustained release Kronofed-A-Jr®, white and clear capsule contains:

INDICATIONS

For temporary relief of upper respiratory and nasal congestion associated with the common cold, hay fever and allergies, sinusitis and vasomotor and allergic rhinitis.

CONTRAINDICATIONS

Severe hypertension or severe cardiac disease. Sensitivity to antihistamines or sympathomimetic agents.

PRECAUTIONS

Use with caution in patients with hyperthyroidism. Patients susceptible to the soporific effects of chlorpheniramine should be warned against driving or operating of machinery which requires complete mental alertness.

PREGNANCY

Pregnancy Category C:  Animal reproduction studies have not been conducted with KRONOFED-A® medications. It is also not known whether KRONOFED-A® medications can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. KRONOFED-A® medications should be given to a pregnant woman only if clearly needed.

Nursing Mothers:  Due to the possible passage of pseudo-ephedrine and chlorpheniramine into breast milk, and, because of the higher than usual risk for infants from sympathomimetic amines and antihistamines, the benefit to the mother vs. the potential risk should be considered and a decision should be made whether to discontinue nursing or to discontinue the drug.

CAUTION

Federal law prohibits dispensing without prescription.

DOSAGE

Kronofed-A® Capsules:  Adults and children over 12 years of age--1 capsule every 12 hours. Kronofed-A-JR® Capsules: Children 6-12 years of age--1 capsule every 12 hours. Adults 1 or 2 capsules every 12 hours.

HOW SUPPLIED

Kronofed-A® Kronocaps

Bottles of 100  NDC 0496-0382-02

Bottles of 500  NDC 0496-0382-10

Kronofed-A-Jr® Kronocaps

Bottles of 100  NDC 0496-0434-02

Bottles of 500  NDC 0496-0434-10