Pharbedryl

Manufacturer
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Effective date
2020-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:00:20

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 exceed 6 doses in 24 hours. Adults and children 12 years of age or over 25 mg to 50 mg (1 to 2 capsules) Children 6 to under 12 years of age 12.5 mg** to 25 mg (1 capsule) Children under 6 years ask a doctor **12.5 mg dosage strength is not available in this package. Do not attempt to break capsule.

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing Store at controlled 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 25 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 or pharmacist before use

OTC - ASK DOCTOR SECTION

If you have

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 of 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

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of each of children.

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 exceed 6 doses in 24 hours.

Adults and children 12 years of age or over

25 mg to 50 mg

(1 to 2 capsules)

Children 6 to under 12 years of age

12.5 mg** to 25 mg (1 capsule)

Children under 6 years

ask a doctor

**12.5 mg dosage strength is not available in this package.

Do not attempt to break capsule.

Other information:

STORAGE AND HANDLING SECTION

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

Questions? Adverse drug event call: (866)562-2756

OTC - QUESTIONS SECTION

Enter section text here

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-445-24

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
70934-44570934-445-24
16103-348

Ingredients#

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

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

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
c8267681-7dec-0d56-e053-2995a90a2962a7993eaf-648e-a818-e053-2995a90a7ea62021-07-27WarningsExact identifier
spl set id: a7993eaf-648e-a818-e053-2995a90a7ea6

Reported adverse events (FAERS/openFDA)#

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