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#
Contacts and useful links#
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
Products#
Every source-derived product name is available through these pages.
- Novex Diphenhydramine
- Diphenhydramine Hydrochloride
- DIPHENHYDRAMINE
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- MAGNESIUM STEARATE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- POLYVINYL ALCOHOL, UNSPECIFIED
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- TALC
- FD&C BLUE NO. 1
- INDIGOTINDISULFONATE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 44237-047 | 44237-047-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e10f5e67-cdc0-4412-9e31-fb7657957bd0 | 7167d03c-448f-422d-a982-d9b852f86f79 | 2021-07-28 | Warnings | 7167d03c-448f-422d-a982-d9b852f86f79 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
