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Diphenhydramine Hydrochloride by Unit Dose Services

Medically reviewed on November 20, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Unit Dose Services
NDC Code: 50436-3594

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 CAPSULES, USP 25mg

Drug Facts

.

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

WARNINGS

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

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

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

    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

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

Keep out of reach of children.

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

Directions
  • take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours adults and children 12 years and over:
  • ask a doctor children under 12 years:

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from moisture
  • For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

Questions or Comments

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

Distributed by: Qualitest Pharmaceuticals, Inc.

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
DIPHENHYDRAMINE HYDROCHLORIDE  
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-3594(NDC:0603-3339)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeAP;020
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-3594-130 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2007
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-3594)

 
Unit Dose Services

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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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