FDA.reportPublic FDA data

Major 44-015-DSP

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:52

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

• do not take more than 6 doses in 24 hours • mL = milliliter; FL OZ = fluid ounce • find right dose on chart below • take every 4 to 6 hours, or as directed by a doctor Age Dose adults and children 12 years and over 2 - 4 teaspoonsful (25 mg to 50 mg) children 6 to 11 years 1 - 2 teaspoonsful (12.5 mg to 25 mg) children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use

Storage and handling

• each teaspoonful (5 mL) contains: sodium 5 mg • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each teaspoonful (5 mL))

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 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

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

  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • use caution when driving a motor vehicle or operating machinery

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

  • do not take more than 6 doses in 24 hours
  • mL = milliliter; FL OZ = fluid ounce
  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor

Age

Dose

adults and children 12 years and over

2 - 4 teaspoonsful (25 mg to 50 mg)

children 6 to 11 years

1 - 2 teaspoonsful (12.5 mg to 25 mg)

children 2 to 5 years

do not use unless directed by a doctor

children under 2 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each teaspoonful (5 mL) contains: sodium 5 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

Relabeled By: Preferred Pharmaceuticals Inc.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 68788-8274-1

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl
Oral Solution

Antihistamine

12.5 mg/5 mL

Institutional Dispensing only

Cherry Flavored
Alcohol Free

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

50844     REV1019A01521
Distributed by: MAJOR® PHARMACEUTICALS
Livonia, MI 48152

Relabeled By: Preferred Pharmaceuticals Inc.

Diphenhydramine HCl Oral Solution 12.5mg/5mL
Diphenhydramine HCl Oral Solution 12.5mg/5mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY5

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
Data codeCode 1281447D3F769D7-3CBB-4469-BFF8-2015619EE115-00.jpg
Data codeData Matrix**032825*D3F769D7-3CBB-4469-BFF8-2015619EE115-00.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
68788-8274-1Diphenhydramine HCl118 mL in 1 BOTTLE, PLASTICSOLUTION1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6985-16ML - Milliliter0904-69856611c1f7-9ef0-4355-bd81-45259ef3f28e12019-10-07
0904-6985-20ML - Milliliter0904-698549dd2649-9d77-4191-9704-1731d6e2495612020-02-13

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
68788-827468788-8274-1
0904-6985

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SUCROSEC151H8M554IACT

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
Diphenhydramine HClDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.d3f769d7-3cbb-4469-bff8-2015619ee1152026-04-06WarningsExact identifier
ndc (package): 68788-8274-1
ndc (product): 68788-8274
ndc11 (package): 68788827401
spl id: 32532b11-59a5-4d31-8206-5a9fc2b76f45
spl set id: d3f769d7-3cbb-4469-bff8-2015619ee115

Reported adverse events (FAERS/openFDA)#

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