DIPHENHYDRAMINE HYDROCHLORIDE tablet

diphenhydramine hydrochloride by

Drug Labeling and Warnings

diphenhydramine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Simpex Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

• runny nose
• sneezing
• Itchy watery eyes
• Itching of the nose or throat.

Warnings

Do not use

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

Consult your doctor if you have

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

Consult your doctor if you are taking sedatives or tranquilizers

• sedative, 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 or reach of children.

In case of overdose, get medical help or contact a poison control center right away.

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks.

Directions:

• take every 4 to 6 hours
• do not take more than 6 does in 24 hours
• Adult and children 12 years of age and over - 1 to 2 tablet
• Children 6 to 12 years of age - 1 tablet
• Children 6 years of age - do not use this product in children under 6 years

Other Information

• each tablet contains: Calcium 25 mg/tablet
• store at room temperature 15°-30° (59°-86° F)
• protect from light and moisture

Inactive ingredient

carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

Package Labeling:

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76457-002
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (round)	Size	8mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76457-002-00	1 in 1 CARTON	02/09/2018
1		100 in 1 BOTTLE; 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	02/09/2018

Labeler - Simpex Pharma Pvt. Ltd (916758275)

Registrant - Simpex Pharma Pvt. Ltd (916758275)

Establishment
Name	Address	ID/FEI	Business Operations
Simpex Pharma Pvt. Ltd		916758275	manufacture(76457-002)