Diphenhydramine Hcl 50mg, Discount Drug Mart, Made In India

SPL v3

SPL

SPL Set ID 116e8192-0c2f-39ed-e063-6294a90abaf3

Route

ORAL

Published

Effective Date 2024-03-28

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 2024-03-20

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

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

MADE IN INDIA

Distributed by: Discount Drug Mart

211 Commerce Drive, Medina, Ohio 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE

WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON

FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

Mfg. Lic. No.: TN00002123

L0000885

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.

64's Count

NDC 53943-485-18

discount

drug

mart

food market

AN EMPLOYEE OWNERSHIP COMPANY

Nighttime Sleep-aid

Diphenhydramine HCl Capsules, USP 50 mg

• Fall asleep fast • Sleep soundly

• Safe, non-habit forming

One Softgel Per Dose

†Compare to the active ingredient in Unisom® SleepGels®

64 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 (1-800-222-1222) 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

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

MADE IN INDIA

Distributed by: Discount Drug Mart

211 Commerce Drive, Medina, Ohio 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

Mfg. Lic. No.: TN00002123

L0000885

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.

64's Count (64's count)

NDC 53943-485-18

discount

drug

mart

food market

AN EMPLOYEE OWNERSHIP COMPANY

Nighttime Sleep-aid

Diphenhydramine HCl Capsules, USP 50 mg

• Fall asleep fast • Sleep soundly

• Safe, non-habit forming

One Softgel Per Dose

†Compare to the active ingredient in Unisom® SleepGels®

64 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 (1-800-222-1222) 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

[{"name": "POLYETHYLENE GLYCOL 600", "unii": "NL4J9F21N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep", "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 †This product is not manufactured or distributed by the owners of Unisom® SleepGels®. MADE IN INDIA Distributed by: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 www.discount-drugmart.com SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256 Mfg. Lic. No.: TN00002123 L0000885 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.", "64's count": "NDC 53943-485-18 discount drug mart food market AN EMPLOYEE OWNERSHIP COMPANY Nighttime Sleep-aid Diphenhydramine HCl Capsules, USP 50 mg • Fall asleep fast • Sleep soundly • Safe, non-habit forming One Softgel Per Dose †Compare to the active ingredient in Unisom® SleepGels® 64 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 (1-800-222-1222) 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.062156 · Updated: 2026-03-14T23:10:46.361818