target diphenhydramine hydrochloride 25 mg softgels - nighttime sleep aid

target diphenhydramine hydrochloride 25 mg softgels - nighttime sleep aid
SPL v2
SPL
SPL Set ID fac83dad-f6fd-3316-e053-6394a90a99aa
Route
oral
Published
Effective Date 2023-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
propylene glycol polyethylene glycol 400 shellac water titanium dioxide fd&c red no. 40 gelatin sorbitol solution fd&c blue no. 1 sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 121 Shape: capsule Color: purple Size: 16 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-01-15
Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Medication Information

Warnings

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Uses

■ for the relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

■ take only one dose per day (24 hours)



adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrs 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

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Description

Diphenhydramine HCl 25 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 50567-7

When using this product

■ avoid alcoholic beverages

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

■ a breathing problem such as 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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Questions Or Comments?

Call 1-800-910-6874

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Warnings

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

Uses

■ for the relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

■ take only one dose per day (24 hours)



adults & children 12 yrs & over

2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrs do not use

Other Information (Other information)

■ store at 20-25° C (68-77°F)

■ avoid excessive heat above 40°C (104°F)

■ protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue no. 1, FD&C red no. 40, gelatin, polyethylene glycol 400, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 50567-7 (50567-7)

When using this product

■ avoid alcoholic beverages

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ a breathing problem such as 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)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

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: 2026-02-15T12:02:41.588470 · Updated: 2026-03-14T23:02:23.126471