NIGHTTIME SLEEP-AID NON-HABIT FORMING- diphenhydramine hci liquid

Nighttime Sleep-Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Uses

■ reduces time to fall asleep if you have difficulty falling asleep
■ for relief of occasional 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 enlarged prostrate gland
■ glaucoma
■ a breathing problem such as asthma, emphysema or chronic bronchitis

ASK DOCTOR/PHARMACIST

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

■ sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of serious underlying medical illness.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

■ take only as recommended
■ Use dosage cup or tablespoon

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

Other information

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

Inactive ingredients

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

QUESTIONS

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

Nighttime Sleep-Aid Label

NDC: 76281-522-28

AP SAFE

*COMPARE TO the
active ingredient in ZzzQUIL™
NIGHTTIME SLEEP-AID

Nighttime
Sleep-Aid

Diphenhydramine HCI

Non-Habit Forming
Not for treating Cold or Flu

Warming Berry
Flavored Liquid

12 FL OZ (354 mL)

DO NOTUSE IF IMPRINTEDSHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Drug Facts

Active ingredient                                                           Purpose
(in each 30 mL dose cup or 2 tablespoons)
Diphenhydramine HCI 50 mg…………………………Nighttime sleep-aid

Uses
■ reduces time to fall asleep if you have difficulty falling asleep
■ for relief of occasional 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 enlarged prostrate 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
■ 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. In case of overdose, get medical help
or contact a Poison Control Center right away. ►

Drug Facts(continued)

Directions
■ take only as recommended
■ Use dosage cup or tablespoon

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

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

Inactive ingredients
citric acid, FD&C Blue #1, FD&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

*This product is not manufactured or distributed by Procter
& Gamble, owner of the registered trademark ZzzQuil™

Manufactured by: AptaPharma Inc.,
1533 Union Ave.,
Pennsauken, NJ 08110

AP-LR-10

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID  NON-HABIT FORMING
diphenhydramine hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-522
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 MONOHYDRATE (UNII: 2968PHW8QP)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-522-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-522) , pack(76281-522) , label(76281-522)