Drug Facts

Active ingredient

(in each caplet)

Diphenhydramine HCI 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

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

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

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.

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)

PRINCIPAL DISPLAY PANEL

Unisom®
SleepMeltsTM
Diphenhydramine HCI tablets, 25 mg
NIGHTTIME SLEEP-AID
24 Tablets

UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0014
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	13mm
Flavor	CHERRY	Imprint Code	U
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41167-0014-0	3 in 1 CARTON	01/01/2008
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:41167-0014-1	4 in 1 CARTON	01/01/2008
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M010	01/01/2008

Labeler - Chattem, Inc. (003336013)

Unisom SleepMelts Nighttime Sleep-Aid