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Diphenhydramine Hydrochloride by Fred's, Inc.

Medically reviewed on January 15, 2018

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: Fred's, Inc.
NDC Code: 55315-356

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.

Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl USP 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 under12 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
  • Do not use with any other products containing Diphenhydramine HCl

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
  • mL = milliliter

adults & children 12 yrs and over
One Dose = 30 mL at bed time if needed or as directed by a doctor

Other information

  • each 30 mL dose contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>.

Inactive ingredients

anhydrous citric acid, ethanol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate.

Questions or Comments

1-855-274-4122

Do not use if printed shrinkband is missing or broken

* This product is not manufactured or distributed by Procter & Gamble distributor of Vicks® ZzzQuil®  NIGHTTIME SLEEP-AID.

DISTRIBUTED BY: fred’s, Inc.
4300 NEW GETWELL RD, MEMPHIS TN 38118
www.fredsinc.com

fred’s Promise Not Happy With This Product? Just Bring It Back For a Refund!

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

freds’s®

NDC 55315-356-31

Nighttime Sleep-Aid

Diphenhydramine HCl

Non-Habit Forming
Warming Berry Flavor

Alcohol 10%

Not for treating Cold or Flu
See Warnings

12 FL OZ
(354 mL)

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-356
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
ANHYDROUS CITRIC ACID 
ALCOHOL 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
BERRY 
HIGH FRUCTOSE CORN SYRUP 
POLYOXYL 40 STEARATE 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-356-31354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33801/31/2015
Labeler - Fred's, Inc. (005866116)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(55315-356)

 
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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