DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actice ingredient

(in each softgel)

Diphenhydramine Hydrochloride USP 25mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratoryallergies:

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

temporarily relieves these symptoms due to the common cold:

runny nose
sneezing

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

. In case of overdose, get medical help or contact aPoison Control Center right away. (1-800-222-1222)

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 1 to 2 capsules
• children 6 to under 12 years: 1 capsule
• children under 6 years: do not use this product in children under 6 years of age

Other Information

store between 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

do not use if carton is open or blister unit is broken

Inactive Ingredients

Propylene Glycol, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified water.

PRINCIPAL DISPLAY PANEL

NDC: 35916-0435-1

Diphenhydramine Hydrochloride USP 25 mg | Antihistamine

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat

DYE-FREE

*liquid-filled capsules

Actual Size

BAR CODE

30 CAPSULES

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0435
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white ((Clear))	Score	score with uneven pieces
Shape	CAPSULE ((Oblong))	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0435-1	3 in 1 CARTON; Type 0: Not a Combination Product	08/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/07/2023

Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(35916-0435)