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Loratadine - Medication Information

Product NDC Code 16571-822
Drug Name

Loratadine

Type Generic
Active Ingredients
Loratadine 10 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 311372
Application Number ANDA214684
Labeler Name Rising Pharmaceuticals, Inc
Packages
Package NDC Code Description
16571-822-01 100 tablet in 1 bottle (16571-822-01)
16571-822-03 30 tablet in 1 bottle (16571-822-03)
16571-822-30 300 tablet in 1 bottle (16571-822-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each tablet) Loratadine, 10 mg USP

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 6 years of age and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
adults and children 6 years of age and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Purpose

Information about the drug product’s indications for use.
Purpose Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Loratadine loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE povidone STARCH, CORN 10;p white to off-white

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30 Count Container Label 100 Count Container Label 30-Count-Label 30ctback 100-Count-Label 100ctback

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken. Store between 20° - 25°C (68°-77°F)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnanct or breast-feeding , ask a health professional before use.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Do not use if you ever have had an allergic reaction to this product or any of its ingredients.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API