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Nighttime Sleep-Aid by DeMoulas Market Basket

Medically reviewed on Apr 3, 2017

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: DeMoulas Market Basket
NDC Code: 53942-522

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.

Nighttime Sleep-Aid 522

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

Diphenhydramine HCL 50 mg

Purpose

Nighttime sleep-aid

Keep out of reach of children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses
  • reduces time to fall asleep if you have difficulty falling asleep
  • for relief of occassional sleeplessness

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Ask a doctor before use if you have
  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid

When using this product
  • do not use more than directed
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • sleepiness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast feeding

ask a health professional before use.

Other information
  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • dosage cup provided
  • store at room temperature

Inactive ingredients

citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Directions
  • take only as recommended
  • use dosage cup or tablespoon

Age                                                              Dose
Adults and children 12 years and over             One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor

Product Label

*COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™ NIGHTTIME SLEEP-AID

Nighttime

SLEEP-AID

Diphenhydramine

Non-Habit Forming

Warming Berry Flavored Liquid

No for treating Cold or Flu

12 FL OZ (354 mL)

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark ZzzQuil™ .

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY, MA 01876

LR-053 Rev 01

DO NOT USE IF IMPRINT SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-522
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53942-522-28354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/19/2013
Labeler - DeMoulas Market Basket (007869647)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(53942-522)

 
DeMoulas Market Basket

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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