Diphenhydramine Oral Solution

Manufacturer
Aldama Pharmaceuticals, Inc
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-03 18:04:14

Label at a glance#

ProductDiphenhydramine Oral Solution
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

Take every 4 hours, as needed, or as directed by a doctor Do not take more than 6 doses in 24 hours adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful Children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL-teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
    • runny nose
    • itchy nose or throat
    • sneezing
    • itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

with any other drug containing diphenhydramine, including one used on the skin.
to make a child sleepy

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing diphenhydramine, including one used on the skin.
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving motor vehicle or operating machinery
  • avoid alcoholic drinks

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

  • Take every 4 hours, as needed, or as directed by a doctor
  • Do not take more than 6 doses in 24 hours
  • adults and children 12 years and over: 10 to 20 ml 2 to 4 teaspoonsful
  • Children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

  • TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing
  • store at room temperature between 15-30°C (59-86°F)
  • do not freeze
  • protect from light
  • Pharmacist: For dispensing, use a light-resistent container with a child-resistant cap

Inactive Ingredient

INACTIVE INGREDIENT SECTION

artificial and natural cherry flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Question or Comments?

OTC - QUESTIONS SECTION

305-592-9216 or info@aldamapharm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

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-130898254002525GTIN-13: 0898254002525
EAN-13: 0898254002525
GTIN-12: 898254002525
UPC-A: 898254002525
GTIN storage (14 digits): 00898254002525
UPDATED.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-81473564-814-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-21full-release2026-06-01 01:34:36

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
58b7b63c-bb86-39e0-e063-6394a90ac13b48ede5ab-207b-cf0c-e063-6394a90a419f2026-08-10WarningsExact identifier
spl set id: 48ede5ab-207b-cf0c-e063-6394a90a419f

Reported adverse events (FAERS/openFDA)#

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