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Nighttime Sleep Aid by Care One (American Sales Company)

Medically reviewed on Nov 14, 2017

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: Care One (American Sales Company)
NDC Code: 41520-034

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.

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
  • 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

NIGHTTIME SLEEP AID 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-034
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
POLYOXYL 40 STEARATE 
WATER 
SODIUM BENZOATE 
SACCHARIN SODIUM ANHYDROUS 
TRISODIUM CITRATE DIHYDRATE 
HIGH FRUCTOSE CORN SYRUP 
FD&C BLUE NO. 1 
ALCOHOL 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-034-06177 mL in 1 BOTTLE, PLASTIC
2NDC:41520-034-12355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2015
Labeler - Care One (American Sales Company) (809183973)

 
Care One (American Sales Company)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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