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DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form
CAPSULE, LIQUID FILLED
Labeler
SOFTGEL HEALTHCARE PRIVATE LIMITED
Label updated
2026-01-27
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Purpose

Nighttime sleep-aid

Uses
  • for relief of occasional sleeplessness
Warnings

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

Principal Display Panel

Compare to the active ingredient Unisom ® SleepGels ®

SleepGels

NDC 35916-0438-1

Diphenhydramine Hydrochloride Capsules USP 50 mg

NIGHTTIME SLEEP-AID

♦ fall asleep fast ♦ sleep soundly

♦ safe, non-habit forming

100 SoftGels**

**liquid-filled capsules

one softgel per dose

[Image in the official label — see DailyMed source]

Bulk Package Label

[Image in the official label — see DailyMed source]

DailyMed Set ID: 0e45d0e8-3741-7cee-e063-6394a90a2de5 · Version 4
NDC: 35916-0438