Nighttime Sleep Aid

Nighttime Sleep Aid
SPL v5
SPL
SPL Set ID 39f5b3bd-262d-4253-a4ee-8d286fbb475f
Route
ORAL
Published
Effective Date 2021-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 602 Shape: oval Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-28
Description

Diphenhydramine Hydrochloride 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine Hydrochloride 25 mg

Uses

• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Carton

Section 42229-5

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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 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 53414-9

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

Warnings

Directions

take only one dose per day (24 hours)

adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor
children under 12 years do not use

Drug Facts

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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Diphenhydramine Hydrochloride 25 mg

Structured Label Content

Uses

• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Carton

Section 42229-5 (42229-5)

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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 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 53414-9 (53414-9)

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

Purpose

Nighttime sleep-aid

Warnings

Directions

take only one dose per day (24 hours)

adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor
children under 12 years do not use

Drug Facts

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#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Diphenhydramine Hydrochloride 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.275736 · Updated: 2026-03-14T23:05:48.377821