NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

Nighttime Sleep-Aid by

Drug Labeling and Warnings

Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by DeMoulas Market Basket, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredientsDRUG 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

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-522
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-522-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	09/19/2013

Labeler - DeMoulas Market Basket (007869647)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53942-522)