Unisom Sleep Melts Nighttime Sleep-aid

SPL v6

SPL

SPL Set ID f50cc038-0973-4c4b-84a7-1c68f41c2410

Route

ORAL

Published

Effective Date 2025-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Citric Acid Monohydrate Crospovidone (120 .mu.m) Dextrose, Unspecified Form Fd&c Red No. 40 Magnesium Stearate Maltodextrin Potassium Citrate Silicon Dioxide Sodium Polystyrene Sulfonate Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: U Shape: round Color: pink Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-01-07

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses

for relief of occasional sleeplessness

Section 42229-5

Drug Facts

Directions

adults and children 12 years of age and over:2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
place 2 tablets on tongue; tablets dissolve with or without water
allow tablets to dissolve in mouth or chew before swallowing

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Active Ingredient

(in each caplet)

Diphenhydramine HCI 25 mg

Other Information

store at room temperature

Inactive Ingredients

citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

* Compare to the Active Ingredient in Unisom® SleepMelts™

Nighttime Sleep Aid

Diphenhydramine HCI Tablets, 25 mg

24 Quick-Dissolving Tablets

Non-Habit Forming

Cherry Flavor

100% SATISFACTION GUARANTEED

Distributed By C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.

*This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™

When Using This Product

avoid alcoholic drinks

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged 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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over:2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
place 2 tablets on tongue; tablets dissolve with or without water
allow tablets to dissolve in mouth or chew before swallowing

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Active Ingredient (Active ingredient)

(in each caplet)

Diphenhydramine HCI 25 mg

Other Information

store at room temperature

Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

* Compare to the Active Ingredient in Unisom® SleepMelts™

Nighttime Sleep Aid

Diphenhydramine HCI Tablets, 25 mg

24 Quick-Dissolving Tablets

Non-Habit Forming

Cherry Flavor

100% SATISFACTION GUARANTEED

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.

*This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™

When Using This Product (When using this product)

avoid alcoholic drinks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

ask a health professional before use.

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 at 1-800-222-1222.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use if You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM POLYSTYRENE SULFONATE", "unii": "1699G8679Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness", "42229-5": "Drug Facts", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor place 2 tablets on tongue; tablets dissolve with or without water allow tablets to dissolve in mouth or chew before swallowing", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Active ingredient": "(in each caplet) Diphenhydramine HCI 25 mg", "Other Information": "store at room temperature", "Inactive ingredients": "citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.", "Questions or comments?": "1-866-467-2748", "PRINCIPAL DISPLAY PANEL": "* Compare to the Active Ingredient in Unisom® SleepMelts™ Nighttime Sleep Aid Diphenhydramine HCI Tablets, 25 mg 24 Quick-Dissolving Tablets Non-Habit Forming Cherry Flavor 100% SATISFACTION GUARANTEED Distributed By C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300 DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING. *This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™", "When using this product": "avoid alcoholic drinks ", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged 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: 2026-02-15T12:07:29.091314 · Updated: 2026-03-14T23:11:00.469021