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DIPHENHYDRAMINE HYDROCHLORIDE by DIRECT RX

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: DIRECT RX
NDC Code: 61919-078

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

OTC - ACTIVE INGREDIENT SECTION

(in each capsule)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Antihistamine

INSTRUCTIONS FOR USE SECTION

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
runny nose
itchy nose or throat
sneezing
itchy, watery eyes

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

OTHER SAFETY 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 INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-078(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 
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:61919-078-2020 CAPSULE in 1 BOTTLE
2NDC:61919-078-9090 CAPSULE in 1 BOTTLE
3NDC:61919-078-3030 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2015
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-078), repack(61919-078)

 
DIRECT RX

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Medically reviewed on Aug 27, 2018

Further information

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

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