Walgreens 613t Diphenhydramine Hcl 25mg Capsule

Walgreens 613t Diphenhydramine Hcl 25mg Capsule
SPL v2
SPL
SPL Set ID 35b78063-e717-2ccb-e063-6394a90a18eb
Route
ORAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Red No. 40 Shellac Fd&c Blue No. 1 Gelatin, Unspecified Water Titanium Dioxide Propylene Glycol Sorbitan Sorbitol Solution Glycerin Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: 121 Shape: capsule Color: purple Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

Directions

  • take only one dose (2 softgels) 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

Description

Drug Facts

Section 42229-5

Drug Facts

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

When using this product

  • avoid alcoholic beverages
Section 50567-7

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 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 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Nighttime sleep-aid

Section 55106-9

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Section 60561-8

Other information

  • store at 20-25° C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Dosage and Administration (34068-7)

Directions

  • take only one dose (2 softgels) 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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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)

When using this product

  • avoid alcoholic beverages
Section 50567-7 (50567-7)

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 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 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Section 60561-8 (60561-8)

Other information

  • store at 20-25° C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.305556 · Updated: 2026-03-14T23:10:05.459246