NIGHTTIME SLEEP-AID- diphenhydramine hcl liquid

Nighttime Sleep-Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Diphenhydramine HCl 50 mg

PURPOSE

Nighttime sleep-aid

USE(S)

• for relief of occasional sleeplessness
• helps you 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 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 DOCTOR IF

sleepleness persists continuously for more than two 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
• only use dosage cup that is included with this product for accurate dosing
• mL = millilitere; Tbsp = teblespoons

• Age: Dose
• adults & chlidren 12 year & over: one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
• childrens under 12 years: do not use

OTHER INFORMATION

• each 30 mL (2 Tbsp) contain: sodium 30 mg
• store at room temperature
• protect from light

INACTIVE INGREDIENTS

citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

PRINCIPAL DISPLAY PANEL

NDC: 53041-633-58

*Compare to the active ingredient in ZZZQUIL® Nighttime Sleep-Aid

Nighttime Sleep-Aid

Warming Berry Flavor

Relieves:

Occasional Sleeplessness

6 FL OZ (177 ML)

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-633
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-633-58	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part338	01/11/2024

Labeler - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(53041-633)