0110-CVS

Manufacturer
CVS Pharmacy, Inc.
Effective date
2026-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-30 01:01:18

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relives symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relives 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 doses in 24 hours adults and children 12 years of age and over 1 caplet children under 12 years of age do not use

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relives symptoms due to hay fever or other upper respiratory allergies:

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

temporarily relives these symptoms due to the common cold:

  • runny nose
  • sneezing

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • marked drowsiness mau 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 brest-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 doses in 24 hours

adults and children 12 years of age and over1 caplet
children under 12 years of agedo not use

Other information

OTHER SAFETY INFORMATION

  • store in a dry place at 15º - 30º C (59º - 86º F).
  • ptotect from moisture

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, mineral oil, silicon dioxide, stearic acid, talc, titanium dioxide, triacetin.

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy CVS.com® 1-800-SHOP CVS
Product of China. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
V-34601

TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN.

RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION.

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Benadryl® Allergy Extra Strength*

Extra Strength

Allergy Relief

Diphenhydramine HCl, 50mg

Antihistamine

Temporatry relief of

Sneezing

Itchy throat

Runny nose

Itchy, watery eyes

24 Caplets

CVS LabelCVS Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-22151316-221-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-02-01full-release2026-06-01 00:08:24

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
1059b55b-c219-843f-e063-6294a90af2fe1059b55b-c218-843f-e063-6294a90af2fe2024-02-01WarningsExact identifier
spl set id: 1059b55b-c218-843f-e063-6294a90af2fe

Reported adverse events (FAERS/openFDA)#

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