FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2020-03-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:38:18

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: runny nose sneezing itching of nose and throat itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing

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 or as directed by a doctor do not give more than directed or exceed the recommended daily dosage Adults and children 12 years of age and over 4 mL Children 6 to 12 years of age 2 mL Children under 6 years of age Ask a doctor use only with enclosed dropper do not use enclosed dropper for any other drug product

Storage and handling

store at controlled room temperature 15°-30°C (59°-86°F) Tamper Evident: Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine/Cough Suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves:
    • runny nose
    • sneezing
    • itching of nose and throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing

Warnings

WARNINGS SECTION

  • May cause excitability, especially in children
  • Marked drowsiness may occur
  • Sedatives and tranquilizers may increase drowsiness

Do Not Use

OTC - DO NOT USE SECTION

  • with any other product containing diphenhydramine, even one used on skin

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 an enlarged prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 or as directed by a doctor
  • do not give more than directed or exceed the recommended daily dosage
Adults and children 12 years of age and over4 mL
Children 6 to 12 years of age2 mL
Children under 6 years of ageAsk a doctor
  • use only with enclosed dropper
  • do not use enclosed dropper for any other drug product

Other Information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • Tamper Evident: Do not use if seal is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, FD&C Blue #1, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose

Questions?

OTC - QUESTIONS SECTION

Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-187-30

Diphenhydramine HCl

Each 1 mL contains:
Diphenhydramine HCl
6.25 mg

Antihistamine/Cough Suppressant

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

1 oz. (30 mL)

Westminster
Pharmaceuticals

Principal Display Panel - 30 mL Bottle Carton
Principal Display Panel - 30 mL Bottle Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-187-30ML - Milliliter69367-18795b9b92c-76e0-4bb5-bcc5-eb3d6b206af712018-06-11

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
69367-18769367-187-30

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POTASSIUM CITRATEEE90ONI6FFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
4f43e271-59f0-41fd-8124-f2d055d1fcd7739aedfd-d5b8-4be8-9453-c7229ec79e262018-03-14WarningsExact identifier
spl set id: 739aedfd-d5b8-4be8-9453-c7229ec79e26

Reported adverse events (FAERS/openFDA)#

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