Novex Diphenhydramine

Manufacturer
Herbion Pakistan (Pvt.) Ltd
Effective date
2020-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:36:40

Label at a glance#

ProductNovex Diphenhydramine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose 
  • itchy, watery eyes 
  • itching of the nose or throat

Temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

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

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 over

1 to 2 tablet

children 6 to under 12 years

1 tablet

children under 6 year

do not use

OTHER SAFETY INFORMATION

Other Information:

■ store between 68-77°F (20-25°C). Protect from light.
■
Do not use if blister unit is broken.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Microcrystalline Cellulose, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Carboxymethyl Cellulose Sodium, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Methacrylic Acid Co-Polymer, Talc, FD&C Blue No.1, Indigo Caramine.

OTC - QUESTIONS SECTION

Questions?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday, 9am - 5pm EST 

NDC 44237-047-06 Novex Diphenhydramine ALLERGY Diphenhydramine HCl 25mg | Antihistamine › Sneezing› Runny Nose› Itchy, Watery Eyes› Itchy Throat 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novex Diphenhydramine TabletsNovex Diphenhydramine Tablets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44237-04744237-047-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e10f5e67-cdc0-4412-9e31-fb7657957bd07167d03c-448f-422d-a982-d9b852f86f792021-07-28WarningsExact identifier
spl set id: 7167d03c-448f-422d-a982-d9b852f86f79

Reported adverse events (FAERS/openFDA)#

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