diphenhydramine hcl 50mg, amerisource bergen, made in india

diphenhydramine hcl 50mg, amerisource bergen, made in india
SPL v3
SPL
SPL Set ID 16b2edd2-c16b-5713-e063-6394a90acf46
Route
oral
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (50 mg)
Inactive Ingredients
polyethylene glycol 600 sorbitan fd&c blue no. 1 gelatin polyethylene glycol 400 water glycerin propylene glycol sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: B50 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-04-11

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 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 relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep

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

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, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Description

Diphenhydramine HCl 50 mg

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

Distributed By

AmerisourceBergen

1 West First Ave

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

ABC#: 10287782 Rev: 04/24

†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.

Mfg. Lic. No.: TN00002123

Made in India

L0000887

R0724

Lot No.:

Exp. Date:

60's Count

Compare to the active ingredient in Unisom® SleepGels®

NDC 46122-775-64

GOOD

NEIGHBOR

PHARMACY

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl Capsules, USP 50 mg

Fall Asleep Fast

• sleep soundly • safe, non-habit forming

One Softgel Per Dose

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

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

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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

Warnings

Do not use

■ for children under 12 years of age

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

Uses

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

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

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, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

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

Distributed By

AmerisourceBergen

1 West First Ave

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

ABC#: 10287782 Rev: 04/24

†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.

Mfg. Lic. No.: TN00002123

Made in India

L0000887

R0724

Lot No.:

Exp. Date:

60's Count (60's count)

Compare to the active ingredient in Unisom® SleepGels®

NDC 46122-775-64

GOOD

NEIGHBOR

PHARMACY

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl Capsules, USP 50 mg

Fall Asleep Fast

• sleep soundly • safe, non-habit forming

One Softgel Per Dose

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

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

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

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

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

ask a health professional before use.

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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