Drug Facts
Active ingredients (in each tablet)
Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 70000-0677). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each tablet)
Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg
Antihistamine
Nasal decongestant
Do not use
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| adults and children 12 years of age and over | take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours |
| children under 12 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
Other information
colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid
Questions or Comments?
call 1-855-274-4122
IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.
DISTRIBUTED BY
CARDINAL HEALTH,
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Made in India
LEADER™
NDC 70000-0677-1
NON-DROWSY
12HR Allergy & Congestion Relief
Fexofenadine HCl 60 mg | Pseudoephedrine HCl 120 mg
Extended-Release Tablets, USP
Antihistamine | Nasal Decongestion
Indoor / Outdoor Relief Of:
• Nasal and Sinus Congestion
Due to Colds or Allergies
• Sneezing; Runny Nose; Itchy, Watery Eyes
and Itchy Nose or Throat Due to Allergies
Actual Size
COMPARE TO
ALLEGRA-D®
12 HOUR ALLERGY
& CONGESTION TABLETS
active ingredients*
20 EXTENDED-RELEASE
TABLETS
* Please review the disclaimer below.