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← See all Diphenhydramine Hydrochloride brands

Diphenhydramine Hydrochloride by Advance Pharmaceutical Inc.

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Advance Pharmaceutical Inc.
NDC Code: 17714-023

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.

DIPHENHYDRAMINE HYDROCHLORIDE TABLETS, USP 50mg

Active Ingredient

(in each TABLET)

Diphenhydramine HCl 50 mg

Purpose

Sleep Aid

Uses

 relieves occasional sleeplessness

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years and over: take 1 tablet at bedtime
  • children under 12 years: ask a doctor

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, FD&C blue# 1(Al-lake), Magnesium stearate, microcrystalline cellulose.

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

Call 631-981-4600, 8:30 am to 4:30 pm ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE Tablet, USP 50 MG

ANTIHISTAMINE

NDC: 17714-023-50 – 50 COUNT

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
STARCH, CORN 
Product Characteristics
Colorblue (light) Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeAP;023
Contains    
Packaging
#Item CodePackage Description
1NDC:17714-023-5050 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2012
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063manufacture(17714-023)

 
Advance Pharmaceutical Inc.

← See all Diphenhydramine Hydrochloride brands

Medically reviewed on Oct 30, 2017

Further information

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

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