NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride solution

NIGHTTIME SLEEP-AID by

Drug Labeling and Warnings

NIGHTTIME SLEEP-AID by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (In each 30 mL dose cup)

Diphenhydramine HCl, USP 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
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
• Do not use this product with an antihistamine and/or cough suppressant

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid

When using this product

• avoid alcoholic beverages and other drugs that cause drowsiness
• drowsiness will occur
• be careful when driving a motor vehicle or operating machinery

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.

Overdose warning: Taking more than directed can cause serious health problems. 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)  - see Overdose warning
• use dose cup
• mL = milliliter

• adults & children 12 yrs & over: One Dose = 30 mL at bed time if needed or as directed by a doctor

Other information

• each 30 mL dose contains: sodium 23 mg
• store at room temperature
• protect from light. Does not meet USP <671>.

Inactive ingredients

anhydrous citric acid, ethanol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate.

Questions or Comments

1-855-274-4122

Failure to follow these warnings could result in serious consequences.
Do not use if printed shrinkband is missing or broken.

* This product is not manufactured or distributed by Procter & Gamble distributor of Vicks® ZzzQuil®  NIGHTTIME SLEEP-AID.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

NDC: 58602-520-16

Primary Health

COMPARE TO Vicks® ZzzQuil®
NIGHTTIME SLEEP-AID
active ingredient*
 Nighttime
Sleep-aid

Diphenhydramine HCl

• Non-Habit Forming

 Not for treating Cold or Flu
See Warnings

Alcohol 10%

Warming Berry Flavor

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-520
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-520-16	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	09/05/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-520)