OTC Medication Information: Sound Body Childrens Allergy Relief

SOUND BODY CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution
Big Lots Stores, 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.

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:
sneezing
itching of the nose or throat
runny nose
itchy, watery eyes

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if the 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
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

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
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

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

each 5 mL contains: sodium 15 mg
store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Children’s Benadryl® Allergy Liquid

RELIEF OF:

Runny Nose – Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

CHILDREN’S

Allergy Relief

Diphenhydramine HCl 12.5 mg / 5 mL Oral Solution

Antihistamine

4-6 HOURS/DOSE

ALCOHOL FREE

Cherry Flavor

4 FL OZ (118 mL)

children's allergy relief image
(click image for full-size original)
SOUND BODY CHILDRENS ALLERGY RELIEF
diphenhydramine hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-013
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SORBITOL
GLYCERIN
Product Characteristics
Color RED (Bluish-Red) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50594-013-26 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (50594-013-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/12/2016
Labeler — Big Lots Stores, Inc. (017885351)

Revised: 08/2017 Big Lots Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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