Label at a glance#

ProductChildrens Allergy

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure13 sections

Contacts and useful links#

PhoneLabel contact1-877-798-5944

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient
(in each 5 mL teaspoon)

Diphenhydramine HCL 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

Uses
■ Temporarily relieves these symptoms
due to hay fever or other respiratory allergies:
   ■ sneezing
   ■ itching of the nose or throat
   ■ runny nose
   ■ itchy watery eyes
■ temporarily relieves these symptoms due to
the common cold:
   ■ sneezing
   ■ runny nose

WARNINGS SECTION

Warnings
Do not use ■ with any other product containing
diphenhydramine, even one used on skin
■ to make a child sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has
■ glaucoma
■ abreathing problem such as chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the
child is taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

■ marked drowsiness may occur
■ excitability may occur, especially in children
■ sedatives and tranquilizers may increase
drowsiness

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of
overdose, get medical help or contact a Poison
Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions■ if needed, take every 4-6 hours■ do not take more than 6 doses in 24 hours


Children under 4 years of age:	do not use
Children 4 to under 6 years of age:	do not use unless directed by a doctor
Children 6 to under 12 years of age:	1 to 2 teaspoonfuls (12.5 mg to 25 mg)

OTHER SAFETY INFORMATION

Other Information

■ Keep carton for full directions for use
■ each teaspoonful contains: sodium 10 mg
■ store at 20° - 25° C(68° - 77° F)
■ dosage cup provided

INACTIVE INGREDIENT SECTION

Inactive ingredients
Citric acid, D&C Red # 33, FD&C Red # 40, flavor,
glycerin, poloxamer 407, purified water, sodium
benzoate, sodium chloride, sodium citrate, sucrose

OTC - QUESTIONS SECTION

Questions or comments?Call weekdays
from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE NDC 72681-505-24

COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL ^®
ALLERGY LIQUID*

Children's
Allergy
Relief

DIPHENHYDRAMINE HCl
Liquid
Antihistamine

Relieves: Sneezing,
Runny Nose,
Itchy Watery Eyes,
Itchy Throat

• Alcohol-Free

4 FL OZ (118 mL) Cherry Flavor

DO NOT USE IF PRINTED SEAL
UNDER CAP IS TORN OR MISSING

2
1013430
3/20

*This product is not manufactured or
distributed by McNeil PPC, Inc., distributor
of Benadryl ^®Allergy liquid.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

AP-BX-03

Carton

505-24 Box

Bottle

505-24 Btl

res

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1049906	diphenhydrAMINE (Oral Liquid)	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76281-505-24	Childrens Allergy	118 mL in 1 BOTTLE	LIQUID	118		5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Childrens Allergy
DIPHENHYDRAMINE HYDROCHLORIDE
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE
SUCROSE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76281-505	76281-505-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	AptaPharma Inc.	b2cef61f-ab54-4a20-a7f7-6d3da4754e8b	2025-12-26	Warnings	Exact identifier ndc (package): 76281-505-24 ndc (product): 76281-505 ndc11 (package): 76281050524 spl id: 46e2e387-098c-8f8f-e063-6294a90add68 spl set id: b2cef61f-ab54-4a20-a7f7-6d3da4754e8b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Childrens Allergy