Nighttime
11b7c200-b79f-4e35-9d53-00f021fa43b0
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Medication Information
Warnings and Precautions
Purpose
Nighttime sleep-aid
Description
Diphenhydramine HCl 25 mg
Uses
● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Section 50566-9
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid
Section 50569-3
Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland
Section 50570-1
Do not use ● for children under 12 years of age ● with any other product containing diphenhydramine, even one used on skin
Section 51945-4
PRINCIPAL DISPLAY PANEL
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Directions
take only one dose per day (24 hours)
| adults & children 12 years & over | One dose = TWO 25 mg softgels (50 mg) at
bed time 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) and high humidity
● Protect from light
Inactive Ingredients
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.
Questions Or Comments?
1-888-333-9792
Active Ingredient (in Each Softgel)
Diphenhydramine HCl 25 mg
Structured Label Content
Uses
● for the relief of occasional sleeplessness ● reduces time to fall asleep if you have difficulty falling asleep
Warnings and Precautions (34071-1)
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Section 50566-9 (50566-9)
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers or any other sleep aid
Section 50569-3 (50569-3)
Ask a doctor before use if you have ● a breathing problem such as asthma, emphysema, or chronic bronchitis ● glaucoma ● difficulty in urination due to enlargement of the prostate gland
Section 50570-1 (50570-1)
Do not use ● for children under 12 years of age ● with any other product containing diphenhydramine, even one used on skin
Section 51945-4 (51945-4)
PRINCIPAL DISPLAY PANEL
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Nighttime sleep-aid
Directions
take only one dose per day (24 hours)
| adults & children 12 years & over | One dose = TWO 25 mg softgels (50 mg) at
bed time if needed or as directed by a doctor |
| children under 12 years | do not use |
Other Information (Other information)
● store at 20-25° C (68-77° F) ● avoid excessive heat above 40° C (104° F) and high humidity
● Protect from light
Inactive Ingredients (Inactive ingredients)
FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide.
Questions Or Comments? (Questions or comments?)
1-888-333-9792
Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))
Diphenhydramine HCl 25 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:04:55.853770 · Updated: 2026-03-14T23:06:06.305155