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Drug Facts
Distributed by: Foundation Consumer Brands, LLC
Pittsburgh, PA 15212
Alavert Tablet, Film Coated, Extended Release
FDA Label NDC 80070-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foundation Consumer Brands for the product Alavert (NDC 80070-100). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Loratadine 5 mg | Antihistamine |
| Pseudoephedrine sulfate 120 mg | 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.
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- 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?
Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST
Principal Display Panel - 24 Tablet Blister Pack Carton
Compare ours to the Active Ingredients in
Claritin-D® 12 Hour Tablets†
allergy & congestion
ALAVERT®
D-12
HOUR
Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
Loratadine 5 mg/Antihistamine – Extended Release Tablets
Non-Drowsy*
Relief of:
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing • Runny Nose • Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies
Indoor & Outdoor Allergies
*When taken as directed. See Drug Facts Panel.
24 TABLETS
Actual Size
Principal Display Panel (24 Tablet Blister Pack Carton)
* Please review the disclaimer below.
