NIGHTTIME SLEEP AID liquid

Nighttime Sleep Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient(s)

Diphenhydramine HCl 50mg

In each 30mL dose cup or 2 tablespoons

Purpose

Nighttime sleep-aid

Use(s)

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

Warnings

Do not use

• Do not use n 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

• 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

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

If pregnant or breastfeeding,

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.

Directions

• take only as recommended
• use dosage cup or tablespoon

Age                                   Dose
Adults & children

12 years & over: One Dose = 2 tablespoons (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 (2 tablespoons) contains: sodium 23 mg
• dosage cup provided
• store at room temperature
• do not use if imprinted shrink band is missing or broken

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/Comments

Call 1-888-952-0050 Monday through Friday 9AM to 5PM

Principal Display Panel

Nighttime Sleep Aid

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
nighttime sleep aid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-446
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 (UNII: FST467XS7D)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-446-39	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	01/16/2024

Labeler - Allegiant Health (079501930)