UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule

Unisom SleepMinis Nighttime Sleep-Aid by

Drug Labeling and Warnings

Unisom SleepMinis 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 mini-capsule)

Diphenhydramine HCI 25 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: 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

blue 1, citric acid, gelatin, lactose, polysorbate 80, potassium sorbate, pregelatinized corn starch, red 3, titanium dioxide (309-121)

PRINCIPAL DISPLAY PANEL

Unisom
#1 Pharmacist Recommended Ingredient*
SleepMinis
Diphenhydramine HCI
Mini-Capsules, 25 mg
NIGHTTIME SLEEP-AID
20 Mini-Capsules

INGREDIENTS AND APPEARANCE

UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0067
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (with a blue band)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	Unisom
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0067-2	1 in 1 CARTON	04/01/2015
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 41167-0067-0	1 in 1 CARTON	04/01/2015
2		60 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	04/01/2015

Labeler - Chattem, Inc. (003336013)