UNISOM SLEEPGELS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled 
Chattem, Inc.

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Unisom SleepGels Nighttime

Drug Facts

Active ingredient

(in each softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

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 persist 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

Inactive ingredients

blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide, water (309-153)

PRINCIPAL DISPLAY PANEL

Unisom
SleepGels
Diphenhydramine HCI
SoftGels, 50 mg
#1 Pharmacist Recommended Brand*
NIGHTTIME SLEEP-AID
32 SoftGels
One SoftGel per dose

Unisom
SleepGels
Diphenhydramine HCI 
SoftGels, 50 mg
#1 Pharmacist Recommended Brand*
NIGHTTIME SLEEP-AID
32 SoftGels
One SoftGel per dose

UNISOM SLEEPGELS NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0061
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code UNISOM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0061-01 in 1 CARTON01/01/2007
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0061-12 in 1 CARTON01/01/2007
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0061-31 in 1 CARTON01/01/2007
332 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:41167-0061-61 in 1 CARTON01/01/2007
460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41167-0061-21 in 1 CARTON09/15/2017
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:41167-0061-51 in 1 CARTON01/01/2007
640 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01001/01/2007
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: d168834c-70ea-4f2c-9a77-bf8a2a7fb384
Set id: 17383d22-91cc-4d9e-a0b8-3f7d9a18af83
Version: 8
Effective Time: 20231009
 
Chattem, Inc.