CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

P & L Development, LLC

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 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 sneezing itchy, watery eyes itching of the nose or throat - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat

Authorization status:

OTC monograph final

Summary of Product characteristics

CHILDRENS ALLERGY- DIPHENHYDRAMINE HYDROCHLORIDE LIQUID
P & L DEVELOPMENT, LLC
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH 5 ML)
Diphenhydramine HCl 12.5 mg
PURPOSE
Antihistamine
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
runny nose
sneezing
itchy, watery eyes
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
a sodium-restricted diet
ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
taking sedatives or tranquilizers.
WHEN USING THIS PRODUCT
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness
excitability may occur, especially in children
KEEP OUT OF THE REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-
1222) right away.
DIRECTIONS
do not take more than 6 doses in 24 hours
take every 4 to 6 hours, or as directed by a doctor
measure only with dosing cup provided. Do not use any other dosing
device.
mL = milliliter
keep dosing cup with product
find the right dose on the chart below
Age (yrs)
Dose (mL)
children 6 to 11 years 5 mL to 10 mL
children 2 to 5 years
do not use unless directed by a doctor
children under 2 years do not use
OTHER INFORMATION
EACH 5 ML CONTAINS: sodium 6 mg
store between 20-25ºC (68-77F). Do not refrigerate.
Protect from light.
INACTIVE INGREDIENTS
anhydrous citric acid, D&C red #33, FD&C red #40 flavors, glycerin,
poloxamer 407,
purified water, sodium benzoate, sodium chloride, sodium citrate,
sucrose
QUESTIONS OR COMMENTS?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient Children's Benadryl® Allergy*
Children's
allergy relief
Oral Solution
Diphenhydramine HCl 12.5 mg
antihistamine
relieves:
sneezing
running nose
itchy, watery eyes
itching of the nose or throat
for ages 6 to 11
alcohol free
cherry flavor
FL