UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule 
Chattem, Inc.

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Unisom SleepMinis Nighttime Sleep-Aid

Drug Facts

Active ingredient

(in each mini-capsule)

Diphenhydramine HCI 25 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, 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
60 Mini-Capsules

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

UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0067
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
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
Colorblue (with a blue band) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code SleepMinis
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0067-21 in 1 CARTON04/01/201507/31/2020
120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:41167-0067-01 in 1 CARTON04/01/2015
260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/01/2015
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: 642938f2-c175-4b20-981e-8fa15db2c06f
Set id: a9a44c2f-65eb-4a5a-9e72-43652dce57f7
Version: 7
Effective Time: 20231009
 
Chattem, Inc.