NOVEX DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, film coated

Novex Diphenhydramine by

Drug Labeling and Warnings

Novex Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl 25mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

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

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

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.

QUESTIONS

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

INGREDIENTS AND APPEARANCE

NOVEX DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-047
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-047-06	3 in 1 CARTON	04/09/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/09/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-047)