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Allergy relief - Medication Information

Product NDC Code 11673-986
Drug Name

Allergy relief

Type Brand
Active Ingredients
Loratadine 10 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 828269
Application Number ANDA206214
Labeler Name TARGET CORPORATION
Packages
Package NDC Code Description
11673-986-07 10 capsule, liquid filled in 1 blister pack (11673-986-07)
11673-986-30 30 capsule, liquid filled in 1 blister pack (11673-986-30)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS iN EACH CAPSULE: LORATADINE 10MG
iN EACH CAPSULE: LORATADINE 10MG

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.
ADULTS AND CHILDREN 6 YEARS AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE 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 AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE 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 FD&C blue#1, gelati, mono and diglyceride of car FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.

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.
INDICATIONS AND USAGE TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES: RUNNY NOSE ITCHY, WATERY EYES SNEEZING ITCHING OF THE NOSE OR THROAT
TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES: RUNNY NOSE ITCHY, WATERY EYES SNEEZING ITCHING OF THE NOSE OR THROAT

Purpose

Information about the drug product’s indications for use.
ANTIHISTAMINE
ANTIHISTAMINE

Spl product data elements

Usually a list of ingredients in a drug product.
ALLERGY RELIEF LORATADINE LORATADINE LORATADINE POVIDONE CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES FD&C BLUE NO. 1 GELATIN SORBITOL WATER POLYSORBATE 80 (light blue) 21

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.
10 CT BLISTER 10 CT 30 COUNT BLISTER 30 CT

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.
IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Storage and handling

Information about safe storage and handling of the drug product.
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) PROTECT FROM FREEZING
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) PROTECT FROM FREEZING

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.
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS. 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. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS. 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. IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

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