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Nighttime Sleep Aid by fred's, Inc.

Medically reviewed on January 1, 2018

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 50mg in 30mL
Labeler: fred's, Inc.
NDC Code: 55315-003

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Nighttime Sleep Aid

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 & overOne 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®*

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Citric Acid Monohydrate 
Sorbitol 
Saccharin Sodium 
Alcohol 
FD&C RED NO. 40 
Sodium Citrate 
Glycerin 
FD&C Blue NO. 1 
Water 
Product Characteristics
ColorPURPLE (Dark) Score    
ShapeSize
FlavorCHERRY, BERRY, STRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-003-12177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33810/23/2013
Labeler - fred's, Inc. (005866116)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(55315-003), PACK(55315-003), LABEL(55315-003), ANALYSIS(55315-003)

 
fred's, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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