unisom sleepmelts nighttime sleep-aid

SPL v10

SPL

SPL Set ID 9105f4f1-7f94-408d-a025-83afb68dc9f0

Route

oral

Published

Effective Date 2026-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

citric acid monohydrate ethylcelluloses hydroxypropyl cellulose (1600000 wamw) mannitol cellulose, microcrystalline povidone d&c red no. 7 starch, corn sucralose sucrose

Identifiers & Packaging

Pill Appearance

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

Marketing Status

otc monograph drug active Since 2008-01-01 Until 2014-10-31

Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Uses

for relief of occasional sleeplessness

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

Inactive Ingredients

citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154)

Dist. by: CHATTEM, Inc.

P.O. Box 2219, Chattanooga, TN 37409 USA

© 2011 Chattem Inc. www.chattem.com

Description

Drug Facts

Principal Display Panel

Unisom ^®

Sleep Melts ^TM

D iphenhydramine HCI tablets, 25 mg

NIGHTTIME SLEEP-AID

24 Tablets

Section 42229-5

Drug Facts

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

Ask A Doctor Before Use

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

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.

Ask A Doctor Or Pharmacist Before Use

taking sedatives or tranquilizers

Structured Label Content

Uses

for relief of occasional sleeplessness

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

Inactive Ingredients (Inactive ingredients)

citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Unisom ^®

Sleep Melts ^TM

D iphenhydramine HCI tablets, 25 mg

NIGHTTIME SLEEP-AID

24 Tablets

Section 42229-5 (42229-5)

Drug Facts

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

Ask A Doctor Before Use (Ask a doctor before use)

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

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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

taking sedatives or tranquilizers

Advanced Ingredient Data

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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", "Inactive ingredients": "citric acid, ethylcellulose, flavor, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, PVP, red 7, starch, sucralose, sucrose (309-154) Dist. by: CHATTEM, Inc. P.O. Box 2219, Chattanooga, TN 37409 USA © 2011 Chattem Inc. www.chattem.com ", "Ask a doctor before use": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "PRINCIPAL DISPLAY PANEL": "Unisom ® Sleep Melts TM D iphenhydramine HCI tablets, 25 mg NIGHTTIME SLEEP-AID 24 Tablets", "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.", "Ask a doctor or pharmacist before use": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:11.606114 · Updated: 2026-03-14T23:12:21.703136