Diphenhydramine Hcl 50mg

Diphenhydramine Hcl 50mg
SPL v2
SPL
SPL Set ID fed2f7ae-2829-f967-e053-6294a90adc0a
Route
ORAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: P50 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-12

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 manufacturerd 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

R0523

L0000720

Warnings

Do not use

  • for children under 12 years of age
  • with any product containing diphenhydramine, even one used on skin.
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
60's Carton

Best

Choice®

*Compare to the

active ingredient in

Unisom®

SleepGels®

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**

**LIQUID-FILLED CAPSULES

Other Information
  • store at 20 oC to 25 oC (68 oF to 77 oF)
  • avoid high humidity and excessive heat above 40 oC (104 oF).
  • protect from light
Inactive Ingredients

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

Questions Or Comments?

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 Centre 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

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 manufacturerd 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

R0523

L0000720

Purpose

Nighttime sleep-aid

Warnings

Do not use

  • for children under 12 years of age
  • with any product containing diphenhydramine, even one used on skin.
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
60's Carton (60's carton)

Best

Choice®

*Compare to the

active ingredient in

Unisom®

SleepGels®

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**

**LIQUID-FILLED CAPSULES

Other Information (Other information)
  • store at 20 oC to 25 oC (68 oF to 77 oF)
  • avoid high humidity and excessive heat above 40 oC (104 oF).
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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 Centre 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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)