Your browser does not support JavaScript! UNISOM SLEEPMELTS (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]
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RxNorm Names

UNISOM SLEEPMELTS (diphenhydramine hydrochloride) tablet, chewable
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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 sleep melts (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
© 2008 Chattem Inc. www.chattem.com 

PRINCIPAL DISPLAY PANEL

Unisom®
SleepMeltsTM 
Diphenhydramine HCI
NIGHTTIME SLEEP-AID
25 mg per tablet

PRINCIPAL DISPLAY PANEL

UNISOM SLEEPMELTS 
diphenhydramine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
ETHYLCELLULOSES 
HYDROXYPROPYL CELLULOSE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
D&C RED NO. 7 
STARCH, CORN 
SUCRALOSE 
SUCROSE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorCHERRYImprint Code U
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0014-03 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33801/01/2008
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Eurand, Inc.097916506MANUFACTURE

Revised: 01/2011
Document Id: dc50f666-7eba-4545-8840-2cbb209acfb8
Set id: 9105f4f1-7f94-408d-a025-83afb68dc9f0
Version: 1
Effective Time: 20110120
 
Chattem, Inc.

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