UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet, chewable

Unisom SleepMelts Nighttime Sleep-Aid by

Drug Labeling and Warnings

Unisom SleepMelts Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 (245-236)

Dist. by: CHATTEM, Inc.
P.O. Box 2219, Chattanooga, TN 37409 USA
© 2011 Chattem Inc. www.chattem.com 

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	01/01/2008

Labeler - Chattem, Inc. (003336013)