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IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Cefaclor for Oral Suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:
The most frequently occurring adverse reactions related to cefaclor therapy include: gastrointestinal symptoms, including diarrhea (2.5%); hypersensitivity reactions including morbilliform eruptions (1.5%); and serum-sickness-like reactions (≤0.5%).

DRUG INTERACTIONS:
Increase in anticoagulant effect may occur when cefaclor is used concomitantly with oral anticoagulants.

USE IN PEDIATRIC PATIENTS:
Safety and effectiveness of cefaclor has not been established in pediatric patients less than 1 month of age.

INDICATIONS FOR USE: Cefaclor for Oral Suspension is indicated for the treatment of otitis media, lower respiratory tract infections, pharyngitis and tonsillitis, urinary tract infections, and skin and skin structure infections caused by susceptible strains of the designated microorganisms:

*Note: β-lactamase-negative, ampicillin-resistant strains (BLNAR) of Haemophilus influenzae should be considered resistant to Cefaclor.

Before prescribing Cefaclor for Oral Suspension, please read the Full Prescribing Information.

To report suspected adverse reactions, please contact FSC at 1-866-764-7822 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch