Valu Merchandisers-diphenhydramine Hcl Capsules, 50 Mg

Valu Merchandisers-diphenhydramine Hcl Capsules, 50 Mg
SPL v4
SPL
SPL Set ID 08a38cd2-04ae-1ef9-e063-6294a90a8868
Route
ORAL
Published
Effective Date 2024-04-30
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 2024-05-01

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

BEST CHOICE 66729 0923 BP

T00186 R0124

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

PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC. KANSAS CITY, KANSAS 66106

For product information please visit: bestchoicebrand.com/66729

MADE IN INDIA

Mfg. Lic. No.: TN00002123

L0000889

R0724

Lot No.:

Exp. Date:

Warnings

Do not use

■ for children under 12 years of age

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

60's Count

Best

Choice

*Compare to the

active ingredient in

Unisom®

SleepGels®

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

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

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

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

BEST CHOICE 66729 0923 BP

T00186 R0124

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

PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC. KANSAS CITY, KANSAS 66106

For product information please visit: bestchoicebrand.com/66729

MADE IN INDIA

Mfg. Lic. No.: TN00002123

L0000889

R0724

Lot No.:

Exp. Date:

Purpose

Nighttime sleep-aid

Warnings

Do not use

■ for children under 12 years of age

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

60's Count (60's count)

Best

Choice

*Compare to the

active ingredient in

Unisom®

SleepGels®

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

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

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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