FDA.reportPublic FDA data

Allergy Relief

Manufacturer
CVS PHARMACY | LNK International, Inc.
Effective date
2025-05-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:00:47

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

chew or crush tablets completely before swallowing; do not swallow tablets whole 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 and over 1 to 2 chewable tablets children 6 to under 12 years 1 chewable tablet children under 6 years do not use

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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
  • difficulty in urination due to enlargement of the 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • 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 and over1 to 2 chewable tablets
children 6 to under 12 years1 chewable tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS Health® 

Chewable Tablets

NDC 69842-685-44

Allergy Relief

DIPHENHYDRAMINE
HYDROCHLORIDE, 25 mg
CHEWABLE TABLETS
Antihistamine

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

For Ages 6 Years & Over

18 CHEWABLE TABLETS

Actual Size

Grape Flavored

Chew or crush
tablets completely
before swallowing.

TAMPER EVIDENT: DO NOT
USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS
TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-18615

50844     REV0119B68544

100% money back
guaranteed.
CVS.com/returnpolicy

CVS 44-685
CVS 44-685

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2046528diphenhydrAMINE HCl 25 MG Chewable TabletPSN10
2046528diphenhydramine hydrochloride 25 MG Chewable TabletSCD10
2046528diphenhydramine HCl 25 MG Chewable TabletSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-685-44Allergy Relief3 in 1 CARTONTABLET, CHEWABLE310
69842-685-44Allergy Relief6 in 1 BLISTER PACKTABLET, CHEWABLE610

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-685ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [CVS PHARMACY]10Legacy NDC, 2 package rows20250512_4e388604-a4cb-4f34-bfdf-4bbc09739b34.zip

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
69842-68569842-685-44

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

Source Document#

Source XML · Source PDF

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
1921537b-8127-44a8-81ae-37b04e0c63f74e388604-a4cb-4f34-bfdf-4bbc09739b342025-05-10WarningsExact identifier
spl id: 1921537b-8127-44a8-81ae-37b04e0c63f7
spl set id: 4e388604-a4cb-4f34-bfdf-4bbc09739b34

Reported adverse events (FAERS/openFDA)#

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