Diphenhydramine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- Strive Pharmaceuticals Inc.
- Label updated
- 2025-01-03
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
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.
Label information
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 over | take 1 softgel (50mg) at bedtime if needed, or as directed by a doctor |
| children under 12 years | do 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
Label information
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
[Image in the official label — see DailyMed source]
[Image in the official label — see DailyMed source]
DailyMed Set ID: 971515fa-b4d2-1197-e053-2995a90a838d · Version 5
NDC: 70692-785