Diphenhydramine Hcl 50mg, A+ Health, Made In India

SPL v2

SPL

SPL Set ID 141b00b7-a283-40ab-e063-6294a90aec77

Route

ORAL

Published

Effective Date 2025-12-01

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 2024-03-21

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.

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

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

Made in India

L0001147

R0925

Mfg. Lic. No.: TN00002123

29006970

Lot No.:

Exp. Date:

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

160's Count

Compare tothe active ingredient in Unisom ^® SleepGels ^®

NDC 69452-427-79

a+ health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules USP, 50 mg

fall asleep fast

sleep soundly

safe, non-habit

forming

one softgel per dose

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

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

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.

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

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

Made in India

L0001147

R0925

Mfg. Lic. No.: TN00002123

29006970

Lot No.:

Exp. Date:

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

160's Count (160's count)

Compare tothe active ingredient in Unisom ^® SleepGels ^®

NDC 69452-427-79

a+ health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules USP, 50 mg

fall asleep fast

sleep soundly

safe, non-habit

forming

one softgel per dose

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

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

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. This product is not manufactured or distributed by the owners of Unisom ® SleepGels ® . Manufactured for: Bionpharma Inc. Princeton, NJ 08540 Made in India L0001147 R0925 Mfg. Lic. No.: TN00002123 29006970 Lot No.: Exp. Date:", "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", "160's count": "Compare to the active ingredient in Unisom ® SleepGels ® NDC 69452-427-79 a+ health maximum strength nighttime sleep-aid diphenhydramine HCl capsules USP, 50 mg fall asleep fast sleep soundly safe, non-habit forming one softgel per dose 160 softgels ** **liquid-filled capsules", "Other information": "store at 20 o C to 25 o C (68 o F to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o 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?": "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", "Ask a doctor or pharmacist before use": "if you are taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.065439 · Updated: 2026-03-14T23:10:46.361818