BASIC CARE NIGHTTIME SLEEP AID- diphenhydramine hcl solution
Amazon.com Services LLC

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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Amazon 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 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

Non-Habit Forming

Compare to Vicks® ZzzQuil® active ingredient

Nighttime Sleep-Aid

Diphenhydramine HCl

50 mg per 30 mL

Not for treating Cold or Flu

10% ALCOHOL

#1 Doctor recommended sleep-aid active ingredient

Berry Flavor

12 FL OZ (355 mL)

BASIC CARE NIGHTTIME SLEEP AID
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72288-186
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:72288-186-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	08/06/2021

Labeler - Amazon.com Services LLC (128990418)

Revised: 8/2021

Document Id: 027de5ea-5c07-4960-8a98-8cf2c0e54a92

Set id: 027de5ea-5c07-4960-8a98-8cf2c0e54a92

Version: 1

Effective Time: 20210806

Amazon.com Services LLC