Aurozzil nighttime sleep-aid solution

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 dosecontains: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

Ingredients and appearance - Product information

Aurozzil nighttime sleep-aid solution- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-024
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
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 Flavor BERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part338 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-024)

Package label-principal display panel 6 fl oz (177 ml bottle)

AUROHEALTH

Compare to the active ingredient in
Vicks ®ZzzQuil ®NIGHTTIME SLEEP-AID*

NDC 58602-024-18

AuroZzil
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

  • Non-Habit Forming
  • Warming Berry Flavor

Alcohol 10%

Not for treating Cold or Flu
See Warnings

6 FL OZ (177 mL)

Package label-principal display panel 12 fl oz (354 ml bottle)

AUROHEALTH

Compare to the active ingredient in
Vicks® ZzzQuil® NIGHTTIME SLEEP-AID*

NDC 58602-024-16

AuroZzil
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

  • Non-Habit Forming
  • Warming Berry Flavor


Alcohol 10%

Not for treating Cold or Flu
See Warnings

12 FL OZ (354 mL)

Package label-principal display panel two 12 fl oz (354 ml bottles)

VALUE
Twin Pack

AUROHEALTH

Compare to the active ingredient in
Vicks® ZzzQuil® NIGHTTIME SLEEP-AID*

NDC 58602-024-31

AuroZzil
NIGHTTIME SLEEP-AID

Diphenhydramine HCl

  • Non-Habit Forming
  • Warming Berry Flavor

Not for treating Cold or FluTotal 24 FLOZ (708 mL)

See Warnings Alcohol 10%Two 12 FL OZ (354 mL) Bottles