Active Ingredient(In Each Capsule)
Loratadine 10 mg
Loratadine Softgels
FDA Label NDC 49035-686
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Loratadine Softgels (NDC 49035-686). 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 ingredient(in each capsule), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
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 BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have 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.
- side effects occur.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care 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.
Directions
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.
Other Information
STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)
PROTECT FROM FREEZING
Inactive Ingredients
FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.
Ndc 49035-686-30
Ndc 495035-686-30 (Walmart686t)
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