NIGHTTIME SLEEP AID BERRY FLAVOR- diphenhydramine hydrochloride liquid 
Raritan Pharmaceuticals Inc

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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DRx CHOICE® Nighttime Sleep-Aid

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

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 two 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 right away at 1-800-222-1222.

Directions

take only one dose per day (24 hours)
only use cup provided

adults & children 12yrs & over

One Dose 30 mL at bed time if needed or as directed by a doctor

Children under 12 yrs

do not use

Other information

each 30 mL dose contains: potassium 5 mg, sodium 10 mg
store at room temperature

Inactive ingredients

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

DRx CHOICE®

NDC 68163-730-06

Compare to in ZzzQuil® Nighttime Sleep-Aid active ingredient *

Sleep-Aid

Nighttime

Diphenhydramine HCl

Non-Habit Forming

BERRY FLAVOR

Naturally and Artificially Flavored

Not for treating Cold or Flu See Warnings

6 FL OZ (177 mL)

$1.99 AMAZING NEW VALUE!

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

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

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

DRx Choice Sleep Aid Nighttime Berry Flavor
NIGHTTIME SLEEP AID  BERRY FLAVOR
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-730
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)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRY (Naturally and Artificially) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-730-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/17/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: e9704c5e-a6d0-4c56-8b29-007585c433d5
Set id: 303d7651-9c8f-4a14-9f2c-7181fa0f003e
Version: 5
Effective Time: 20230902
 
Raritan Pharmaceuticals Inc