Sleepaid (diphenhydramine Hydrochloride 50mg Capsule,liquid Filled)

Sleepaid (diphenhydramine Hydrochloride 50mg Capsule,liquid Filled)
SPL v2
SPL
SPL Set ID faaf5d51-d81d-3acc-e053-6294a90ae08f
Route
ORAL
Published
Effective Date 2023-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Glycerin Sorbitol Gelatin Polyethylene Glycol, Unspecified Sorbitan Water

Identifiers & Packaging

Pill Appearance
Imprint: AD1 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-04
Description

Active ingredient (in each soft gel) Diphenhydramine HCL 50 mg

Medication Information

Warnings and Precautions

Warnings

Do not use

  • for children under 12 years of age
  • with any other products 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 persists 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.

Indications and Usage

USES

Use for relief of occasional sleeplessness.

Dosage and Administration

Directions

adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Description

Active ingredient (in each soft gel) Diphenhydramine HCL 50 mg

Section 42229-5

*Compare to active ingredient in Unisom ® SleepGels ®

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

Section 44425-7

Other information

  • store at room temperature 15º to 30º C (59º to 86º F)
  • avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing
Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN.

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

Section 51727-6

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Section 51945-4

NDC 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg

  • Safe, non habit-forming
  • One softgel per dose

Made in USA

100 Soft gels

Section 53413-1

Questions or comments?

  • Call 1-855-642-2594
Section 55105-1

Purpose

Nighttime sleep-aid

Drug Facts

Active ingredient (in each soft gel)

Diphenhydramine HCL 50 mg

Structured Label Content

Indications and Usage (34067-9)

USES

Use for relief of occasional sleeplessness.

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and over: Take 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Warnings and Precautions (34071-1)

Warnings

Do not use

  • for children under 12 years of age
  • with any other products 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 persists 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.

Section 42229-5 (42229-5)

*Compare to active ingredient in Unisom ® SleepGels ®

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ®

Rev.: 03/2023

Manufactured by:

Apnar Pharma LLP

East Windsor, NJ 08520

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15º to 30º C (59º to 86º F)
  • avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing
Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN.

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

Section 51727-6 (51727-6)

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Section 51945-4 (51945-4)

NDC 24689-154-01

SleepAid

Diphenhydramine HCL 50 mg

  • Safe, non habit-forming
  • One softgel per dose

Made in USA

100 Soft gels

Section 53413-1 (53413-1)

Questions or comments?

  • Call 1-855-642-2594
Section 55105-1 (55105-1)

Purpose

Nighttime sleep-aid

Drug Facts (DRUG FACTS)

Active ingredient (in each soft gel)

Diphenhydramine HCL 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.342313 · Updated: 2026-03-14T23:06:57.309434