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

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®*

Principal Display Panel - 177 mL Bottle Label

NIGHTTIME SLEEP AID
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-003
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - fred's, Inc. (005866116)

Registrant - davAgen Pharmaceutical, LLC (967545935)

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

Nighttime Sleep Aid