NIGHTTIME SLEEP AID- diphenhydramine hcl liquid

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• with any other product containing diphenhydramine, even one used on the skin
• for children under 12 years of age
• with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

• heart disease
• glaucoma
• breathing problem such as asthma,emphysema, or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

• drowsiness will occur
• avoid alcoholic drinks and other drugs that cause drowsiness
• 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.

Directions

• take only one dose per day (24 hours) - (see overdose warning)
• mL=milliliter
• measure only with dosing cup provided.Do not use any other dosing device
• keep dosing cup with product
• adults and children 12 years and over
  • one dose=30 mL at bedtime if needed, or as directed by a doctor
• children under 12 years do not use 

Other information

• each 30 mL contains: sodium 23 mg
• store at 20-25ºC (68-77ºF)
• do not refrigerate
• protect from light

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-friday 9AM-5PM EST

Principal Display Panel

Compare to the Active Ingredient in ZZZQUIL®*

NIGHTTIME SLEEP AID

Diphenhydramine HCI 50 mg

Alcohol 10%

Non-Habit-Forming

Not for treating cold or flu

Berry Flavor

FL OZ (mL)

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY

FOODHOLD USA LLC

LANDOVER, MD 20785

1-877-846-9949

Package Label

CAREONE Nighttime Sleep Aid

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-034
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-034-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2015
2	NDC: 41520-034-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2015

Labeler - Care One (American Sales Company) (809183973)