SLEEP AID NIGHTTIME- diphenhydramine hcl liquid 
CVS Pharmacy

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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CVS 44-002A

Active ingredient
(in each 30 mL dose cup)

Diphenhydramine HCl 50 mg
 

Purpose

Nighttime sleep-aid

Uses

  • for 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

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the 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 a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

  • do not take more than directed
  • mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • take only one dose per day (24 hours)
  • adults and children 12 years and over: take 30 mL (2 TBSP) in dosing cup provided at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

  • each 30 mL dose cup contains: sodium 17 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30º C (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVS
Health™

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

Alcohol Free
Nighttime

Sleep Aid
DIPHENHYDRAMINE HCl 50 mg

Nighttime Sleep Aid

Non-habit forming

Not for treating cold or flu

Berry Flavor

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nighttime Sleep Aid.

50844   ORG101700245

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
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V-11112

CVS 44-002

CVS 44-002

SLEEP AID  NIGHTTIME
diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-208
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-208-962 in 1 PACKAGE01/31/2019
1355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:69842-208-02355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2019
3NDC:69842-208-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33801/31/2019
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305MANUFACTURE(69842-208) , PACK(69842-208)

Revised: 10/2019
Document Id: 2feacdf7-7850-4b69-b7d1-b7a510f67369
Set id: 1a862c79-e57a-4a17-8ffc-f8a0b802d3c1
Version: 3
Effective Time: 20191011
 
CVS Pharmacy