Active Ingredients (In Each Tablet)
Loratadine 5 mg
Pseudoephedrine sulfate 120 mg
Leader Allergy Relief D12 Tablet, Film Coated, Extended Release
FDA Label NDC 70000-0504
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader Allergy Relief D12 (NDC 70000-0504). 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 active ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product do not take more than directed., stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
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 depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product Do Not Take More Than Directed.
Taking more than directed may cause drowsiness.
Stop Use And Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- nervousness, dizziness or sleeplessness occurs
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
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 Allergies
Relief of: - Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing – Runny Nose – Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies
COMPARE TO CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS active ingredients
*When Taken as Directed. See Drug Facts Panel.
30 EXTENDED RELEASE TABLETS
Actual Size
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* Please review the disclaimer below.
