NIGHTTIME SLEEP AID- diphenhydramine hcl liquid 
Care One (Retail Business Services, LLC.)

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.

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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


Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages.


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: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 HCL, 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

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

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

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Package Label

Diphenhydramine HCL 50 mg

CARE ONE Nighttime Sleep Aid

NIGHTTIME SLEEP AID 
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-034
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:72476-034-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201906/30/2025
2NDC:72476-034-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201906/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/201906/30/2025
Labeler - Care One (Retail Business Services, LLC.) (967989935)

Revised: 1/2023
Document Id: 18a7dde5-7c8b-4f92-9f3d-98ce3693e488
Set id: c5cfe533-9942-48df-8da3-1846a35da4d5
Version: 4
Effective Time: 20230117
 
Care One (Retail Business Services, LLC.)