FDA.reportPublic FDA data

Pharbedryl

Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises
Effective date
2017-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:30

Label at a glance#

ProductPharbedryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies: Sneezing Nasal congestion Runny nose Itchy, watery eyes

Dosage and administration

Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 capsule                                      Children under 12 years ask a doctor

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing Store at room temperature 15°-30°C (59°-86°F) Protect from moisture Use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient(in each banded capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:

  • Sneezing
  • Nasal congestion
  • Runny nose
  • Itchy, watery eyes

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

  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma

Ask 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 drinks
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful 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 accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
Adults and children 12 years or over
1 capsule                                     
Children under 12 years
ask a doctor

Other information:

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • Store at room temperature 15°-30°C (59°-86°F)
  • Protect from moisture
  • Use by expiration date on package

Questions? Adverse drug event call:

OTC - QUESTIONS SECTION

(866) 562-2756

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of labelimage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-006-302022-01-28C16284748780-1d6a99b39-b6f1-a426-e053-dadaa90af4c2Diphenhydramine 50 mg #30 006 Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-006-30Pharbedryl30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-006PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170915_58ec2343-4c3b-26fa-e053-2a91aa0a4916.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-347-11EA - Each16103-3471c087d47-7f50-486d-9c6d-fc6ee3317b4912012-07-24

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
67046-00667046-006-30
16103-347

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC OXIDEXM0M87F357IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARBEDRYLDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.a19f1edc-d2cf-45fc-8233-d882441b02472025-12-24WarningsExact identifier
ndc (product): 16103-347
58ec2343-4c3c-26fa-e053-2a91aa0a491658ec2343-4c3b-26fa-e053-2a91aa0a49162017-09-11WarningsExact identifier
spl id: 58ec2343-4c3c-26fa-e053-2a91aa0a4916
spl set id: 58ec2343-4c3b-26fa-e053-2a91aa0a4916

Reported adverse events (FAERS/openFDA)#

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