FDA.reportPublic FDA data

Antihistamine - Gendose Pharmaceuticals, LLC

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:33

Label at a glance#

ProductAntihistamine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 exceed 6 doses in 24 hours adults and children 12 years and older: 1 capsule to 2 capsules children 6 to under 12 years: 1 capsule children under 6 years: do not use this product in children under 6 years of age

Storage and handling

store at 20° - 25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to 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

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours or as directed by a doctor
  • do not take exceed 6 doses in 24 hours
  • adults and children 12 years and older: 1 capsule to 2 capsules
  • children 6 to under 12 years: 1 capsule
  • children under 6 years: do not use this product in children under 6 years of age

Other information

STORAGE AND HANDLING SECTION

  • store at 20° - 25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, corn starch, D&C Red #28, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, lactose anhydrous, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-676-7161

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1

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
BarcodeDataBar Omni(01)00377333227108GTIN-14: 00377333227108
GTIN-12: 377333227108
UPC-A: 377333227108
EAN-13: 0377333227108
GTIN storage (14 digits): 00377333227108		label.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
77333-227-10Antihistamine100 in 1 BOXCAPSULE1001
77333-227-25Antihistamine1 in 1 BLISTER PACKCAPSULE11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77333-22777333-227-25, 77333-227-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BUTYLPARABEN3QPI1U3FV8IACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
ndc (package): 77333-227-25
ndc (package): 77333-227-10
ndc (product): 77333-227
ndc11 (package): 77333022710
ndc11 (package): 77333022725
spl id: 50faaa96-1783-eb34-e063-6394a90ab4f2
spl set id: 847cdee8-410f-4ff3-9245-976ed6f4c776

Reported adverse events (FAERS/openFDA)#

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