ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl

Manufacturer
Cabinet Health P.B.C.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:31

Label at a glance#

ProductValuMeds Allergy Relief Antihistamine Diphenhydramine HCl
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 itchy nose or throat temporarily relieves these symptoms of the 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 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#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

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
  • itchy nose or throat
  • temporarily relieves these symptoms of the cold:
  • runny nose
  • sneezing

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

  • trouble urinating due to an enlarged prostate gland 
  • glaucoma

Ask your doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • taking the blood thinning drug warfarin

Ask your 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

  • 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 (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 and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use

Other information

SPL UNCLASSIFIED SECTION

  • protect from moisture
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, d&c red 27, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc

Questions or Comments?

OTC - QUESTIONS SECTION

contact 1-908-242-6108 Mon- Fri 8:00 AM EST to 5:00 PM PST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterLabel.jpgOuterLabel.jpg

82725-1101-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 2Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232605352GTIN-13: 0040232605352
EAN-13: 0040232605352
GTIN-12: 040232605352
UPC-A: 040232605352
GTIN storage (14 digits): 00040232605352
OuterLabel.jpg
BarcodeEAN-130850069928001GTIN-13: 0850069928001
EAN-13: 0850069928001
GTIN-12: 850069928001
UPC-A: 850069928001
GTIN storage (14 digits): 00850069928001
label 2.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82725-1101-1ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl600 in 1 BOTTLETABLET6002
82725-1101-2ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl1200 in 1 BOTTLETABLET12002

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
82725-110182725-1101-1, 82725-1101-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ValuMeds Allergy Relief Antihistamine Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.a5ceab90-6885-4f3a-b001-97679e03c01b2025-12-29WarningsExact identifier
ndc (package): 82725-1101-2
ndc (package): 82725-1101-1
ndc (product): 82725-1101
ndc11 (package): 82725110102
ndc11 (package): 82725110101
spl id: 471c7baf-fe0d-269a-e063-6394a90a06b3
spl set id: a5ceab90-6885-4f3a-b001-97679e03c01b

Reported adverse events (FAERS/openFDA)#

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