SMART SENSE NIGHTTIME SLEEP AID- diphenhydramine hcl solution
Kmart Corporation

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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Kmart Corporation Nighttime Sleep-Aid Drug Facts

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

•: for the 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 emphysema or chronic bronchitis
•: glaucoma
•: difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•: avoid alcoholic beverages

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 (1-800-222-1222).

Directions

•: take only one dose per day (24 hours)
•: only use the dose cup provided

adults & children 12 yrs & over	30 mL at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

Other information

•: each 30 mL contains: sodium 20 mg
•: store at 20-25˚C (68-77˚F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN VICKS® ZzzQUIL®

nighttime sleep-aid

DIPHENHYDRAMINE HCl 50 mg PER 30 mL

BERRY FLAVOR

#1 doctor recommended sleep-aid active ingredient

non-habit forming

10% ALCOHOL

NOT FOR TREATING COLD OR FLU

6 FL OZ (177 mL)

SMART SENSE NIGHTTIME SLEEP AID
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-186
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 in 30 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49738-186-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2015	10/31/2019
2	NDC:49738-186-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2017	08/03/2019
3	NDC:49738-186-50	2 in 1 PACKAGE	04/29/2017	07/20/2019
3		355 mL in 1 BOTTLE; 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	10/21/2015	10/31/2019

Labeler - Kmart Corporation (008965873)

Revised: 1/2021

Document Id: 1c649515-5d03-41ac-9a68-3ee7e16216b0

Set id: b6965d50-6203-48b9-8aa7-553975a20444

Version: 4

Effective Time: 20210113

Kmart Corporation