Diphenhydramine hydrochloride solution

Drug facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl USP 50 mg


Nighttime sleep-aid


  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep


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 aretaking 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 ifsleeplessness 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).


  • 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 dosecontains: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


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.


freds Promise Not Happy With This Product? Just Bring It Back For a Refund!

Ingredients and appearance - Product information

Diphenhydramine hydrochloride solution- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 55315-356
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 50 mgin 30 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Alcohol ( UNII: 3K9958V90M)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Polyoxyl 40 stearate ( UNII: 13A4J4NH9I)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium benzoate ( UNII: OJ245FE5EU)
Trisodium citrate dihydrate ( UNII: B22547B95K)

Product Characteristics



# Item Code Package Description Marketing Start Date
1 NDC: 55315-356-31 354mL in 1 BOTTLE 2015/01/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part338 USA 2015/01/31

Labeler - Fred's, Inc.( 005866116)


Name ID/FEI Business Operations
Fred's, Inc. 005866116 MANUFACTURE( 55315-356)

Package label-principal display panel 12 fl oz (354 ml bottle)

fredss ®

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)