Label: LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 70000-0504-1, 70000-0504-2, 70000-0504-3
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 17, 2021

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  • Active ingredients (in each tablet)
    Loratadine 5 mg - Pseudoephedrine sulfate 120 mg
  • Purpose
    Antihistamine - Nasal decongestant
  • Uses
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing - • itchy, watery eyes - • runny nose - • itching of the nose or throat - • temporarily relieves ...
  • Warnings
    Do not use - • if you have ever had an allergic reaction to this product or any of its ingredients - • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for ...
  • Directions
    • do not divide, crush, chew or dissolve the tablet - adults and children 12 years and over - 1 tablet every 12 hours; not more than 2 tablets in 24 hours - children under 12 years of ...
  • Other information
    • each tablet contains: calcium 25 mg - • do not use if blister unit is broken or torn - • store between 20° to 25°C (68° to 77°F) • keep in a dry place
  • Inactive ingredients
    croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide
  • Questions or comments?
    1-800-719-9260
  • Package/Label Principal Display Panel
    Non-Drowsy* | 12 Hour - Allergy Relief D-12 - Pseudoephedrine Sulfate, 120 mg | Loratadine, 5 mg - Extended-Release Tablets - Nasal Decongestant | Antihistamine - Allergy and Congestion - Indoor and Outdoor ...
  • INGREDIENTS AND APPEARANCE
    Product Information