Diphenhydramine HCl Oral Solution Drug Facts

Manufacturer: CVS Pharmacy, Inc. | Aurohealth LLC
Effective date: 2020-11-27
Label type: Human OTC Drug Label
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 23:04:57

Label at a glance#

ProductDye-Free Adult ALLERGY

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

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours not to exceed 300 mg in 24 hours mL = milliliter Age (yr) Dose (mL) Adult and children 12 years and older 10 mL to 20 mL Children under 12 years Consult a doctor Attention : use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

Active Ingredient [in each 20 mL]

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl, USP 50 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

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet
trouble urinating due to enlarged prostate

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

marked drowsiness may occur
avoid alcoholic drinks
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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
not to exceed 300 mg in 24 hours
mL = milliliter

Age (yr)	Dose (mL)
Adult and children 12 years and older	10 mL to 20 mL
Children under 12 years	Consult a doctor

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

Other information

SPL UNCLASSIFIED SECTION

each 20 mL contains: sodium 56 mg
store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or Comments?

1-855-274-4122

DO NOT USE IF SEAL UNDER CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com^® 1-800-SHOP CVS
Product of India
V-31735

CVS^® Quality
Money Back Guarantee

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health_TM

NDC 59779-195-24

MAXIMUM STRENGTH
Adult
Allergy
Relief
LIQUID MEDICATION
DIPHENHYDRAMINE HCl
50 mg/20 mL
ORAL SOLUTION
Antihistamine

Dye Free

Relieves:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat

Cherry Flavor

Alcohol Free

Actual Bottle Size on Side Panel

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Dye-Free Adult ALLERGY
Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
ANHYDROUS CITRIC ACID
CHERRY
HIGH FRUCTOSE CORN SYRUP
POLOXAMER 407
WATER
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59779-195	59779-195-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
CHERRY	BUC5I9595W	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 272 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	SOLUTION / ORAL	50 mg/5ml		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
POLOXAMER 407	POLOXAMER 407	TUF2IVW3M2	CAPSULE / ORAL		468 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION / ORAL		20000 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / SUBCUTANEOUS		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / OPHTHALMIC		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAVENOUS		1152 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATUMOR	1.2 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates

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
29a0a185-c88c-4f68-83d5-f19d95314020			cb7c020c-13ec-4936-a51f-4cbfbb3952f8	2020-11-27	Warnings	Exact identifier spl id: 29a0a185-c88c-4f68-83d5-f19d95314020 spl set id: cb7c020c-13ec-4936-a51f-4cbfbb3952f8

Reported adverse events (FAERS/openFDA)#

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