Loratadine And Pseudoephedrine
FDA Label NDC 54868-5656

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Loratadine And Pseudoephedrine (NDC 54868-5656). 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

→ 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,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Package Label. Principal Display Panel

Active Ingredients (In Each Tablet)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 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 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 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. (for blister carton/label)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle carton/label)
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