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Diphenhydramine hydrochloride by Central Texas Community Health Centers

Medically reviewed on Mar 22, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Central Texas Community Health Centers
NDC Code: 76413-306

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

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

Do not use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children 

If pregnant of 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
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours 
 adults and children 12
 years of age and over
 1 to 2 capsules
 children 6 to under 12
 years of age
 1 capsule
 children under 6
 years of age
 do not use this product
 in children under 6
 years of age

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture 

Inactive ingredients

butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silica gel

Questions or comments?

1-800-616-2471

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton Label

CommUnityCare Federally Qualified Health Centers

DIPHENHYDRAMINE
25mg/24 Caps

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

DIPHENHYDRAMINE 25mg/24 CAPS NDC 76413-306-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-306(NDC:0904-2035)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
GELATIN 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
METHYLPARABEN 
PROPYLPARABEN 
POLYSORBATE 80 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code44;107
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-306-242 BLISTER PACK in 1 CARTON
112 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/15/1990
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-306), RELABEL(76413-306)

 
Central Texas Community Health Centers

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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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