Label at a glance#

ProductDiphenhydramine Hcl

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies • sneezing • runny nose • itchy, watery eyes • itching of the nose or throat

Dosage and administration

• 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 (yr) 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

Storage and handling

• Each 5 mL contains: Sodium 0.03 mg • store between 20-25°C (68-77°F). Do not refrigerate. • protect from light. Store in outer carton until contents are used.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-826-1306

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
• sneezing • runny nose • itchy, watery eyes • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use
• with any other product containing diphenhydramine, even one used on the 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
• sedatives and tranquilizers may increase drowsiness
• excitability may occur, especially in children

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 (yr)	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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, Methylparaben Sodium, Propylparaben Sodium, Sodium Benzoate, Sucralose, sorbitol, Citric acid monohydrate, D&C red #33, FD&C red #40, flavor & purified water.

Other information

STORAGE AND HANDLING SECTION

• Each 5 mL contains: Sodium 0.03 mg
• store between 20-25°C (68-77°F). Do not refrigerate.
• protect from light. Store in outer carton until contents are used.

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Children's Benadryl^® Allergy

Relief of Runny Nose, Sneezing, Itchy Throat & Itchy, Watery Eyes

For Ages 6 to 11 Years

Alcohol Free

Cherry Flavor

* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl^® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by:
Delsam Pharma Llc
Bronx, Newyork 10467.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphen1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72570-101-04	2023-03-16	C162847	48780-1	9d75b9d0-375a-f424-e053-dadaa90a57ce	Diphenhydramine Hcl 12.5 mg Oral Solution
72570-101-04	2020-01-31	C162847	48780-1	9d75b9d0-375a-f424-e053-dadaa90a57ce	Diphenhydramine Hcl 12.5 mg Oral Solution

Products#

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

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

Diphenhydramine Hcl
Diphenhydramine hydrochloride
DIPHENHYDRAMINE
GLYCERIN
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
SODIUM BENZOATE
SUCRALOSE
SORBITOL
CITRIC ACID MONOHYDRATE
D&C RED NO. 33
FD&C RED NO. 40
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72570-101	72570-101-04

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
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
SORBITOL	506T60A25R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
WATER	059QF0KO0R	IACT

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
425bb83d-47c4-4db0-bc2d-4be6f0ca410b			9a6a6d0a-ee5e-47dd-923e-d84be48c6054	2023-03-15	Warnings	Exact identifier spl set id: 9a6a6d0a-ee5e-47dd-923e-d84be48c6054

Reported adverse events (FAERS/openFDA)#

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

Diphenhydramine Hcl 12.5 mg Oral Solution