DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled 
SOFTGEL HEALTHCARE PRIVATE LIMITED

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Diphenhydramine Hydrochloride Capsules, USP 25 mg

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 over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo 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.

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

Diphenhydramine Hydrochloride Capsules USP 25 mg Carton

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0435
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite ((Clear)) Scorescore with uneven pieces
ShapeCAPSULE ((Oblong)) Size15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0435-13 in 1 CARTON; Type 0: Not a Combination Product08/07/2023
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/07/2023
Labeler - SOFTGEL HEALTHCARE PRIVATE LIMITED (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0435)

Revised: 3/2024
Document Id: 147b0ea8-75db-2759-e063-6294a90aa7be
Set id: 0203d919-dc1f-cca0-e063-6394a90aa1aa
Version: 3
Effective Time: 20240325
 
SOFTGEL HEALTHCARE PRIVATE LIMITED