Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ca052b38-de38-7bf0-e053-2995a90a4e85
Route
ORAL
Published
Effective Date 2021-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Gelatin Glycerin Lecithin, Soybean Water Sorbitan Medium-chain Triglycerides Titanium Dioxide Polyethylene Glycol, Unspecified Fd&c Blue No. 1 Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: P50 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-15

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

■ for relief of occasional sleeplessness



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

Section 42229-5

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED

WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Made in USA using domestic and imported materials.

This product is not manufactured or distributed by the

owners of Unisom ® SleepGels ®.

Lot No.:

Exp. Date:

Distributed By

AmerisourceBergen

1 West First Ave

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

L0000442

Rev # 04/21

Directions

■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.



■ swallow whole; do not crush, chew, or dissolve

Do Not Use

■ for children under 12 years of age



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

60's Count Carton

GOOD

NEIGHBOR

PHARMACY®

Compare to the active ingredient in Unisom® SleepGels®†

NDC 46122-695-72

Maximum Strength

Nighttime Sleep-aid

Diphenhydramine HCl Capsules, 50 mg

Fall Asleep Fast

• sleep soundly • safe, non-habit forming

One Softgel Per Dose

60 softgels** I (**Liquid-filled capsules)

Other Information

■ store at 20°C to 25°C (68°F to 77°F)



■ avoid high humidity and excessive heat above 40°C (104°F).



■ protect from light

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product

■ avoid alcoholic beverages



■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Centre right away.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

■ glaucoma



■ a breathing problem such as emphysema or chronic bronchitis



■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use

if you are taking sedatives or tranquilizers.


Structured Label Content

Uses

■ for relief of occasional sleeplessness



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

Section 42229-5 (42229-5)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED

WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Made in USA using domestic and imported materials.

This product is not manufactured or distributed by the

owners of Unisom ® SleepGels ®.

Lot No.:

Exp. Date:

Distributed By

AmerisourceBergen

1 West First Ave

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

L0000442

Rev # 04/21

Purpose

Nighttime sleep-aid

Directions

■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.



■ swallow whole; do not crush, chew, or dissolve

Do Not Use (Do not use)

■ for children under 12 years of age



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

60's Count Carton

GOOD

NEIGHBOR

PHARMACY®

Compare to the active ingredient in Unisom® SleepGels®†

NDC 46122-695-72

Maximum Strength

Nighttime Sleep-aid

Diphenhydramine HCl Capsules, 50 mg

Fall Asleep Fast

• sleep soundly • safe, non-habit forming

One Softgel Per Dose

60 softgels** I (**Liquid-filled capsules)

Other Information (Other information)

■ store at 20°C to 25°C (68°F to 77°F)



■ avoid high humidity and excessive heat above 40°C (104°F).



■ protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

■ avoid alcoholic beverages



■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Centre right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ glaucoma



■ a breathing problem such as emphysema or chronic bronchitis



■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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