Diphenhydramine Hydrochloride 25 MG Oral Tablet

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Pill Identifier Information of Diphenhydramine Hydrochloride 25 MG Oral Tablet

Drug Information

Imprint:	;
Shape:	C48348
Color:	C48325
Ingredients:	Diphenhydramine
Size:	8.00
Score:	1
Rxtty:	SCD
Author:	Simpex Pharma Pvt. Ltd
Inactive Ingredients:	CARNAUBA WAX / SILICON DIOXIDE / CROSCARMELLOSE SODIUM / CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE / HYPROMELLOSES / MAGNESIUM STEARATE / CELLULOSE, MICROCRYSTALLINE / POLYSORBATE 80 / POLYVINYL ALCOHOL / WATER / TALC / TITANIUM DIOXIDE>

Complete Information

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 productÂ 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 toÂ an enlarged prostate gland.
Consult your doctor if you are taking sedatives or tranquilizers
- sedative, and tranquilizers may increase drowsiness
- be careful whenÂ driving a motor vehicle or operating machinery
- excitability may occurÂ 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 controlÂ 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 15Â°-30Â°Â (59Â°-86Â° F)
- protect from light and moisture
Inactive ingredient

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

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDEÂ
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76457-002
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	Â
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	Â
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)	Â
TALC (UNII: 7SEV7J4R1U)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â
XANTHAN GUM (UNII: TTV12P4NEE)	Â
CARNAUBA WAX (UNII: R12CBM0EIZ)	Â
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	Â
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)	Â
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)	Â
MAGNESIUM STEARATE (UNII: 70097M6I30)	Â
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)	Â

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76457-002-00	1 in 1 CARTON	02/09/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	02/09/2018

Labeler -Â Simpex Pharma Pvt. Ltd (916758275)

Registrant -Â Simpex Pharma Pvt. Ltd (916758275)

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