Nighttime Sleep Aid

FRED'S, INC.
davAgen Pharmaceutical, LLC

Nighttime Sleep Aid

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 30 mL or 2 tablespoons)
• Purpose
• Nighttime Sleep Aid Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Nighttime Sleep Aid Other information
• Inactive ingredients
• Questions?
• PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 30 mL or 2 tablespoons)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

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

Nighttime Sleep Aid 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

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