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Loratadine And Pseudoephedrine Sulfate
FDA Label NDC 68016-724
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Loratadine And Pseudoephedrine Sulfate (NDC 68016-724). 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) | Purpose |
|---|---|
| Loratadine, USP 10 mg | Antihistamine |
| Pseudoephedrine sulfate, USP 240 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
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- 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 condtions, 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 daily with a full glass of water; not more than 1 tablet in 24 hours |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- sodium: contains 10 mg/tablet
- calcium: contains 25 mg/tablet
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Storage And Handling
- store between 20° C to 25° C (68° F to 77° F).
- protect from light and store in a dry place
Inactive Ingredients
calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
Questions?
call 1-800-406-7984
Principal Display Panel - 10 Tablet Blister Pack Carton
COMPARE TO THE ACTIVE
INGREDIENTS OF CLARITIN-D® 24 HOUR†
Original Prescription Strength
NON-DROWSY*
Premier
Value®
24 Hour Allergy Relief
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
ALLERGY RELIEF and
NASAL DECONGESTANT
Indoor & Outdoor Allergies
Relief of:
✓ Nasal & Sinus Congestion Due to Colds or Allergies✓ Sneezing; Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose Due to Allergies
10
Allergy & Congestion
Extended-Release Tablets
INDEPENDENTLY TESTED
SATISFACTION GUARANTEED
*When taken as directed. See Drug Facts Panel.
Principal Display Panel (10 Tablet Blister Pack Carton)
* Please review the disclaimer below.
