FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF- diphenhydramine hcl liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Strategic Sourcing Services LLC

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 - to make a child sleepy - with any other product containing diphenhydramine, even one used on skin - glaucoma - a breathing problem such as chronic bronchitis taking sedatives or tranquilizers

Authorization status:

OTC monograph final

Summary of Product characteristics

FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF - DIPHENHYDRAMINE
HCL LIQUID
STRATEGIC SOURCING SERVICES LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF 549
ACTIVE INGREDIENT(S)
Diphenhydramine HCl 12.5 mg
PURPOSE
Antihistamine
USE(S)
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
to make a child sleepy
with any other product containing diphenhydramine, even one used on
skin
ASK A DOCTOR BEFORE USE IF THE CHILD HAS
glaucoma
a breathing problem such as chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
sedatives and tranquilizers may increase drowsiness
marked drowsiness may occur
excitability may occur, especially in children
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
find right dose on chart below
mL=milliliter
measure only with dosing cup provided
do not use dosing cup with other products
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
AGE(YR)
DOSE(ML)
children under 2 years do not use
children 2 to 5 years
do not use unless directed by a doctor
children 6 to 11 years 5 mL to 10 mL
OTHER INFORMATION
EACH 5 ML CONTAINS: sodium 5 mg
dosing cup provided
store between 20°-25°C(68°-77°F)
INACTIVE INGREDIENTS
carboxymethylcellulose sodium, citric acid, flavors, glycerin,
purified water , saccharin
sodium, sodium benzoate, sorbitol.
QUESTIONS OR COMMENTS
Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST
PRINCIPAL DISPLAY PANEL
NDC 70677-1012-2
COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT*
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