PREMIER VALUE NIGHTTIME SLEEP-AID LIQUID SLEEP-AID- diphenhydramine hydrochloride liquid 
Chain Drug Consortium

----------

Premier Value Nighttime Sleep-Aid

Drug Facts

Active ingredients (in each 30 mL dose cup or 2 tablespoons)

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
with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

avoid alcoholic beverages and other drugs that cause drowsiness
drowsiness will occur
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
use dose cup or tablespoon

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Other information

each 30 mL dose (2 tablespoons) contains: sodium 23 mg
store at room temperature
protect from light. Does not meet USP <671>.

Inactive ingredients

anhydrous citric acid, carboxymethylcelluose sodium, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Failure to follow these warnings could result in serious consequences

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™.

Distributed by:

Chain Drug Consortium LLC.

3301 N.W. Boca Raton Blvd.

Suite 101, Boca Raton FL 33431

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

Premier Value
Nighttime

Sleep-Aid

Diphenhydramine HCl /

Non-Habit Forming

Berry Flavor

Not for treating Cold or Flu
See Warnings

12 FL OZ (354 ml)

Premier Value Nighttime Sleep Aid
PREMIER VALUE NIGHTTIME SLEEP-AID LIQUID  SLEEP-AID
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-219
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-219-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/10/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01012/10/2012
Labeler - Chain Drug Consortium (101668460)

Revised: 11/2023
Document Id: be25a6ab-f708-4dc3-ae06-400a722557dc
Set id: 6d24b6e1-7959-47c6-a09b-c7e00a437495
Version: 6
Effective Time: 20231106
 
Chain Drug Consortium