FDA Label for Equaline Childrens Allergy Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Equaline Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
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
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
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.
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
adults and children 6 years and over | chew 2 tablets daily; not more than 2 tablets in 24 hours |
children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 tablet in 24 hours |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
• phenylketonurics: contains phenylalanine 1.4 mg per tablet• do not use if blister unit is broken or torn• store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions Or Comments?
1-877-932-7948
Package/Label Principal Display Panel
compare to Children’s Claritin® Chewables active ingredient
children’s
allergy relief
loratadine chewable tablets, 5 mg
(antihistamine)
indoor & outdoor allergies
non-drowsy*
24 hour relief of:
sneezing – runny nose
itchy, watery eyes
itchy throat or nose
ages 2 years and older
actual size
grape flavor
20 chewable tablets
*WHEN TAKEN AS DIRECTED.
SEE DRUG FACTS PANEL.
* Please review the disclaimer below.