DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled 
Softgel Healthcare Pvt Ltd

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Diphenhydramine Hydrochloride Capsules USP 50 mg

Active ingredient

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Do not use

for children under 12 years of age
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

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 a Poison Control Center right away.

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

Bottle Label

Bottle Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35916-0438
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorblue ((Transparent)) Scorescore with uneven pieces
ShapeCAPSULE ((Oval)) Size13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35916-0438-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/11/2024
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01001/10/2024
Labeler - Softgel Healthcare Pvt Ltd (675584180)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(35916-0438)

Revised: 3/2024
Document Id: 147b532d-45e0-5b60-e063-6294a90a018d
Set id: 0e45d0e8-3741-7cee-e063-6394a90a2de5
Version: 2
Effective Time: 20240325
 
Softgel Healthcare Pvt Ltd