Diphenhydramine Hydrochloride - CVS Pharmacy, Inc

Manufacturer
CVS Pharmacy, Inc
Effective date
2026-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-30 01:02:11

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and 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 ■ Temporarily relieves these symptoms due to the common cold: ■ Runny nose ■ Sneezing

Dosage and administration

■ Take every 4 to 6 hours, or as directed by a doctor ■ Do not take more than 6 times in 24 hours Adults and children 12 years and over 1 to 2 tablets Children 6 to under 12 years 1 tablet Children under 6 years do not use

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

Uses

INDICATIONS & USAGE SECTION

■ 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

■ Temporarily relieves these symptoms due to the common cold: ■ Runny nose ■ Sneezing

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

■ 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 emphysema or chronic bronchitis
■ Glaucoma
■ Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

■ Marked drowsiness may occur
■ Avoid alcoholic drinks
■ Alcohol, sedatives, and tranquilizers may increase drowsiness

■ Be careful when driving a motor vehicle or operating machinery
■ Excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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 times in 24 hours

Adults and children 12 years and over 1 to 2 tablets
Children 6 to under 12 years 1 tablet
Children under 6 years do not use

Other information

OTHER SAFETY INFORMATION

■ Each tablet contains: calcium 37 mg
■ Store between 20-25° C (68-77° F). Protect from light.

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Silica, Stearic Acid, Talc, Titanium Dioxide and Triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy LIQUIGELS®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2020 CVS/pharmacy CVS.com®
1-800-SHOP CVS
Product of China
V-34601

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the active ingredient in Benadryl® Allergy LIQUIGELS®*

Allergy Relief

Diphehydramine HCl, 25 mg

Antihistamine

Relief of: Sneezing; Runny nose; Itchy,watery eyes; Itchy throat

200 Tablets

CVS LabelCVS Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-98169842-981-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-02full-release2026-06-01 00:41:02

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incb45296a9-e3f0-a4cb-e053-2995a90a16862024-12-02WarningsExact identifier
ndc (package): 69842-981-08
ndc (product): 69842-981
ndc11 (package): 69842098108
spl set id: b45296a9-e3f0-a4cb-e053-2995a90a1686

Reported adverse events (FAERS/openFDA)#

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