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Diphenhydramine Hydrochloride

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Strive Pharmaceuticals Inc.
Label updated
2025-01-03
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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