CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION- 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:

CVS PHARMACY, INC.

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

CVS PHARMACY PRE-MEASURED SPOON CHILDRENS ALLERGY MEDICATION-
DIPHENHYDRAMINE HYDROCHLORIDE LIQUID
CVS PHARMACY, INC.
_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._
----------
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)*
Diphenhydramine HCl 12.5 mg
*5 mL = one pre-filled spoon
PURPOS E
Antihistamine
US ES
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 YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
a sodium-restricted diet
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or
tranquilizers
WHEN USING THIS PRODUCT
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children
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
refer to chart below
take every 4 to 6 hours
do not take more than 6 doses in 24 hours
Children under 2 years of age
do not use
Children 2 to 5 years of age
do not use unless directed by a doctor
Children 6 to 11 years of age
1 to 2 pre-filled spoons (12.5 mg to 25
mg)
Adults and children 12 years of age
and over
2 to 4 pre-filled spoons (25 mg to 50
mg)
OTHER INFORMATION
each pre-filled spoon contains: SODIUM 14 MG
store between 20-25°C (68-77°F).
Protect from light. Store in outer carton until contents used.
SAFETY SEALED: THIS PRODUCT IS PROTECTED BY A SEALED POUCH.