CHILDRENS ALLERGY fexofenadine hydrochloride suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)

Available from:

Supervalu Inc

INN (International Name):

FEXOFENADINE HYDROCHLORIDE

Composition:

FEXOFENADINE HYDROCHLORIDE 30 mg in 5 mL

Prescription type:

OTC DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHILDRENS ALLERGY- FEXOFENADINE HYDROCHLORIDE SUSPENSION
SUPERVALU INC
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CHILDRENS ALLERGY FEXOFENADINE HYDROCHLORIDE ORAL SUSPENSION
_DRUG FACTS_
ACTIVE INGREDIENT
(in each 5 mL= 1 teaspoonful)
Fexofenadine HCl, USP 30 mg
ACTIVE INGREDIENT
ACTIVE INGREDIENT
(in each 5 mL= 1 teaspoonful)
Fexofenadine HCl, USP 30 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 kidney disease. Your doctor should
determine if you need a
different dose.
WHEN USING THIS PRODUCT:
• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)
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.
DIRECTIONS
• shake well before using
• use only with enclosed dosing cup
adults and children 12 years of age and over
take 2 teaspoonfuls (10 mL) every 12 hours; do not take
adults and children 12 years of age and over
more than 4 teaspoonfuls (20 mL) in 24 hours
children 2 to under 12 years of age
take 1 teaspoonful (5 mL) every 12 hours; do not take
more than 2 teaspoonfuls (10 mL) in 24 hours
children under 2 years of age
ask a doctor
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor
OTHER INFORMATION
• each 5 mL (1 teaspoonful) contains: SODIUM 18 MG
• safety sealed: do not use if carton, unprinted foil inner seal, or
neckband printed with “SEALED FOR
YOUR PROTECTION” is opened, torn or missing.
•store between 20° to 25°C (68° to 77°F).
•before using any medica