NIGHTTIME SLEEP AID- diphenhydramine hcl liquid 
Care One (American Sales Company)

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Drug Facts

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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


Other information

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

Diphenhydramine HCI 50 mg

CAREONE Nighttime Sleep Aid

NIGHTTIME SLEEP AID 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-034-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
2NDC:41520-034-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/30/2015
Labeler - Care One (American Sales Company) (809183973)

Revised: 3/2024
Document Id: a80a1b48-b8e2-443e-993e-eeb1262b92ba
Set id: bd5de3b3-7cb5-4403-b664-23ac70b9957f
Version: 6
Effective Time: 20240304
 
Care One (American Sales Company)