UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride tablet, chewable

Unisom SleepMelts Nighttime Sleep-Aid by

Drug Labeling and Warnings

Unisom SleepMelts Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each caplet)

Diphenhydramine HCI 25 mg

Purpose

Nighttime sleep-aid

Uses

• 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 persists 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 at 1-800-222-1222.

Directions

• adults and children 12 years of age and over: 2 tablets (25 mg each) at bedtime if needed, or as directed by a doctor
  
• place 2 tablets on tongue; tablets dissolve with or without water
  
• allow tablets to dissolve in mouth or chew before swallowing

Other Information

• store at room temperature

Inactive ingredients

citric acid, crospovidone, dextrose. FD&C RED # 40, flavor, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

*Compare to the Active Ingredient in Unisom® SleepMelts™

Nighttime Sleep Aid
Diphenhydramine HCI Tablets, 25 mg
24 Quick-Dissolving Tablets

Non-Habit Forming

Cherry Flavor

100% SATISFACTION GUARANTEED

Distributed By C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.

*This product is not manufactured or distributed by Chattern Inc., owner of the registered trademark Unisom® SleepMelts™

INGREDIENTS AND APPEARANCE

UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-393
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE (UNII: 68401960MK)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	13mm
Flavor	CHERRY	Imprint Code	U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-393-24	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/07/2019

Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)