CHILDRENS LORATADINE SUGAR FREE- loratadine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN)

Available from:

American Sales Company

INN (International Name):

Loratadine

Composition:

Loratadine 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHILDRENS LORATADINE SUGAR FREE- LORATADINE SOLUTION
AMERICAN SALES COMPANY
----------
CHILDREN'S LORATADINE ORAL SOLUTION
SUGAR FREE
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
Loratadine 5 mg
PURPOS E
Antihistamine
US ES
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.
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
use only with enclosed dosing cup
adults and children 6 years and over
2 teaspoonfuls (tsp) daily; do
not take more than 2
teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age
1 teaspoonful (tsp) daily; do
not take more than 1
teaspoonful (tsp) in 24 hours
Children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
OTHER INFORMATION
DO NOT USE IF BOTTLE WRAP IMPRINTED WITH "SEALED FOR SAFETY" IS BROKEN
OR MISSING.
see bottom panel for lot number and expiration date
store between 20° and 25°C (68° and 77°F)
INACTIVE INGREDIENTS
butylated hydroxyanisole, glycerin, grape flavor, maltitol solution,
masking agent, phosphoric acid,
polyethylene glycol, propylene glycol, purified water, sodium
benzoate, sodium phosphate monobasic
dihydrate, sorbitol solution, sucralose powder.
QUES TIONS ?
Call _1-866-923-4914_
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
NDC 41520-131-08
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