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 fred's, Inc., davAgen Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL or 2 tablespoons)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time 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 asthma, 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 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.

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. (1-800-222-1222)

Directions

• take only one dose per day (24 hours) – see Overdose warning
• use dose cup or tablespoon

• adults & children 12 yrs & over: One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Other information

• each 30 mL dose (2 tablespoons) contains:
  sodium 21 mg
• store at room temperature
• protect from light. Does not meet USP <671>.

Inactive ingredients

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions?

1-732-249-6363

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

NDC: 55315-003-12
fred's®

Warming
Berry Flavor

Nighttime
Sleep-Aid

Diphenhydramine HCl

Non-Habit Forming
Not for treating Cold
or Flu

Alcohol 10%

See Warnings

6 FL OZ (177 mL)

fred's
LAB TESTED
Lab Tested for Quality
Fred Tested for Satisfaction

Compare To
Vicks ZzzQuil®*

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-003
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
Sodium Benzoate (UNII: OJ245FE5EU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sorbitol (UNII: 506T60A25R)
Saccharin Sodium (UNII: SB8ZUX40TY)
Alcohol (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Sodium Citrate (UNII: 1Q73Q2JULR)
Glycerin (UNII: PDC6A3C0OX)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE (Dark)	Score
Shape		Size
Flavor	CHERRY, BERRY, STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-003-12	177 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	10/23/2013

Labeler - fred's, Inc. (005866116)

Registrant - davAgen Pharmaceutical, LLC (967545935)

Establishment
Name	Address	ID/FEI	Business Operations
davAgen Pharmaceutical, LLC		967545935	MANUFACTURE(55315-003) , PACK(55315-003) , LABEL(55315-003) , ANALYSIS(55315-003)