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

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.

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Unisom SleepGels Nighttime

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 (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 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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part338	01/01/2007

Labeler - Chattem, Inc. (003336013)

Revised: 1/2007

Document Id: 93c2d6bd-94aa-4b89-93f4-07f7e7c1fe11

Set id: 17383d22-91cc-4d9e-a0b8-3f7d9a18af83

Version: 7

Effective Time: 20070101

Chattem, Inc.