FDA.reportPublic FDA data

Pharbedryl

Manufacturer
A-S Medication Solutions
Effective date
2022-09-12
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
legacy-cache
Hydrated at
2026-08-01 21:52:24

Label at a glance#

ProductPharbedryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and above 1-2 capsules        children 6 to under 12 years  1 capsule children under 6 years Ask a doctor

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing store between 20°-25°C (68°-77°F)  protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

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

Warnings

WARNINGS SECTION

Do not use

  • to make 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

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

  • 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 overdose, get medical help or contact a Poison Control Center right away 91-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and above1-2 capsules       
children 6 to under 12 years 1 capsule
children under 6 yearsAsk a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store between 20°-25°C (68°-77°F) 
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, D&C red #28, D&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call (866)562-2756 Mon - Fri 8 AM to 4 PM

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-1638

NDC: 50090-1638-0 30 CAPSULE in a BOTTLE

NDC: 50090-1638-3 20 CAPSULE in a BOTTLE

Diphenhydramine HCl

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1638-02020-02-14C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-12020-02-14C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-22020-02-14C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-32020-02-14C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-82020-02-14C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-02020-01-31C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-12020-01-31C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-22020-01-31C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-32020-01-31C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts
50090-1638-82020-01-31C16284748780-19d75b9d0-c6dc-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1638-0EA - Each50090-16386e13795f-c49e-4ea9-b974-5d6f345a558b12018-08-13
50090-1638-1EA - Each50090-1638159ef4a5-65d8-4c2d-998b-24c1191bbae812018-08-13
50090-1638-2EA - Each50090-1638bbf1a35f-1c23-4237-8954-7cae402ff96112018-08-13
50090-1638-3EA - Each50090-16382f51f7d7-3aad-4663-8e8e-62db2410770612018-08-13
50090-1638-8EA - Each50090-16387383ee7e-9385-4c6a-b519-ebd30079dc7b12018-11-06
16103-348-03EA - Each16103-3485de1d9de-7e1e-4271-80c4-090cadb9fcd812012-07-24
16103-348-08EA - Each16103-34890cd3e96-3e7f-40bb-a237-08d4664982ea12014-12-01
16103-348-11EA - Each16103-3483310a6e3-4317-40ac-a106-9f7606a265f712012-07-24

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
50090-163850090-1638-0, 50090-1638-1, 50090-1638-2, 50090-1638-3, 50090-1638-8
16103-348

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PharbedrylDIPHENHYDRAMINE HCLPharbest Pharmaceuticals, Inc.070e556b-e083-452f-8a7c-aca92470dd612025-12-24WarningsExact identifier
ndc (product): 16103-348
795eb8d3-6d87-4bd4-a726-e27684082806f155295c-4500-4af6-98df-a64cedda385c2022-12-06WarningsExact identifier
spl set id: f155295c-4500-4af6-98df-a64cedda385c

Reported adverse events (FAERS/openFDA)#

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