Unisom SleepMelts

Dosage form: tablet, chewable
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Chattem, Inc.
NDC Code: 41167-0014

Disclaimer: 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.

Unisom SleepMelts

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

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 CodeU
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-0014-03 BLISTER PACK (3 BLISTER PACK) in 1 CARTON
18 TABLET, CHEWABLE (8 TABLET) 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/FEIOperations
Eurand, Inc.097916506MANUFACTURE

Revised: 01/2011
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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