Unisom® Sleep-Aid

Unisom Warming Cherry by

Drug Labeling and Warnings

Unisom Warming Cherry by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNISOM WARMING CHERRY- diphenhydramine hydrochloride liquid 
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® Sleep-Aid

Drug Facts

Active ingredient

(in each 30 mL dose)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

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 asthma, 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 two 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

• use only with the enclosed dosing cup. Wash cup and let air dry after each use.
• adults and children 12 years of age and older: take 2 tablespoons (30 mL) at bedtime if needed, or as directed by a doctor
• do not give to children under 12 years of age

Other Information

• do not use if inner seal is broken or missing
• child-resistant packaging

Inactive ingredients

alcohol (10%), blue 1, citric acid, flavors, glycerin, glycyrrhizic acid, polysorbate 20, propylene glycol, red 40, sodium benzoate, sucralose, water, xylitol (309-093)

PRINCIPAL DISPLAY PANEL

Unisom
NightTime Sleep-Aid
Diphenhydramine HCI, 50 mg/ 30 mL
NON-HABIT FORMING
Fall Asleep Fast
Sleep Soundly
10% Alcohol
Cherry
Flavored Liquid
12 FL OZ (354 mL) 

UNISOM WARMING CHERRY 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0066
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  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZIN (UNII: 6FO62043WK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0066-4	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2013	11/01/2019
2	NDC: 41167-0066-5	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2013	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	12/02/2013	11/01/2019

Labeler - Chattem, Inc. (003336013)

Revised: 12/2019

Document Id: 1d02d58e-f1b3-4948-8eb6-15e677f9d7c0

34390-5

Set id: 6d4de82d-faaf-4217-a211-5c66e5879ba6

Version: 2

Effective Time: 20191216

 

Chattem, Inc.