CHILDRENS ALLERGY RELIEF- diphenhydramine hcl 12.5mg/5ml solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CalmCo 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 • sneezing • itchy, watery eyes • itching of the nose or throat

Authorization status:

OTC monograph final

Summary of Product characteristics

CHILDRENS ALLERGY RELIEF- DIPHENHYDRAMINE HCL 12.5MG/5ML SOLUTION
CALMCO 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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DRKIDS CHILDRENS ALLERGY RELIEF
ACTIVE INGREDIENT (IN EACH 5ML)
Diphenhydramine HCL 12.5mg
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
ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
• a breathing problem such as chronic bronchitis
• glaucoma
• 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 REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control
Center right away (1-
800-222-1222)
DO NOT USE
• to make a child sleepy • with any other product containing
diphenhydramine, even one
used on skin
DIRECTIONS
this product does not contain directions or complete warnings for
adult use
give the recommended number of vials below following the instructions
under Easy
to Use on the side panel
do not take more than 6 doses in any 24 hour period
empty each Single-Use Vial of all liquid when dosing
DOSING CHART
Age
(Years)
Dose
6-11
Years
1 - 2 Single-Use Vials (5mL each) every 4-6 hours. Do not exceed 12
vials in
24 hours
INACTIVE INGREDIENTS
citric acid, glycerin, mixed berry flavor, propylene glycol, purified
water, sodium
benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate,
xanthan gum
OTHER INFORMATION
each Single-Use vial contains 16mg of sodium
store at 68-77ºF (20-25ºC)
tamper evident: do not use if top flap of carton is open. Do not use
if any vials are
open or broken
QUESTIONS