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

Unisom SleepGels Nighttime Sleep-Aid by

Drug Labeling and Warnings

Unisom SleepGels 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 softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

• 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 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

• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide, water (245-189)

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0061
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	UNISOM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0061-0	1 in 1 CARTON	01/01/2007
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0061-1	2 in 1 CARTON	01/01/2007
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0061-2	1 in 1 CARTON	09/15/2017
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 41167-0061-3	1 in 1 CARTON	01/01/2007
4		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 41167-0061-6	1 in 1 CARTON	01/01/2007
5		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 41167-0061-5	1 in 1 CARTON	01/01/2007
6		40 in 1 BOTTLE, PLASTIC; 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	01/01/2007

Labeler - Chattem, Inc. (003336013)