DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule, liquid filled 
Strive Pharmaceuticals Inc.

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Nighttime Sleep-Aid
Diphenhydramine HCl 50mg (Blue Softgel)

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Uses

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have
• glaucoma
• heart disease
• a breathing problem such as emphysema, asthma, or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product • avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if sleeplessness persists 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

adults and children  12 years and overtake 1 softgel (50mg) at bedtime  if needed, or as directed by a  doctor
children under 12  yearsdo not use

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

edible ink, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Compare to the active ingredient of Unisom® SleepGels®*

Maximum Strength

fall asleep fast safe, non-habit forming

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

This product i is not manufactured or distributed by Chatem, Inc., owner of the registered trademark Unisom®.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of UAE

Packaged and Quality Assured in the USA

Packaging

Strive-785-1

Strive-785-2

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-785
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorblue (greenish blue - transparent) Scoreno score
ShapeOVAL (Oblong) Size13mm
FlavorImprint Code 785
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-785-6116 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2019
2NDC:70692-785-15150 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
3NDC:70692-785-71275 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01008/20/2019
Labeler - Strive Pharmaceuticals Inc. (080028013)

Revised: 1/2025
Document Id: aa185f21-9410-4918-b9e5-27f7891578b0
Set id: 971515fa-b4d2-1197-e053-2995a90a838d
Version: 5
Effective Time: 20250103
 
Strive Pharmaceuticals Inc.