Other
Drug Facts
Distributed by McKesson
One Post Street, San Francisco, CA 94104
Sunmark
FDA Label NDC 49348-849
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Sunmark (NDC 49348-849). 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, active ingredient (in each 5 ml), purpose, uses, 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
Active Ingredient (In Each 5 Ml)
Loratadine 5 mg
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
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.
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.
Directions
| adults and children 6 years and over | 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 2° and 25°C (36° and 77°F)
Inactive Ingredients
artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
sunmark®
COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*
NDC 49348 849-34
24 HOUR
ALLERGY RELIEF
children's
loratadine
syrup
(Loratadine Oral Solution)
5 mg/5 mL Antihistamine
Relief of
sneezing, runny nose
itchy, watery eyes
itchy throat or nose
Dye Free
Non-drowsy†
Ages two years & older
GRAPE FLAVOR
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
Principal Display Panel (120 mL Bottle Carton)
* Please review the disclaimer below.
