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Diphenhydramine Hydrochloride by Rite Aid Corporation

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rite Aid Corporation
NDC Code: 11822-6415

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.

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine  

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • 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 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. (1-800-222-1222)

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo not use this product in children under 6 years of age

Other information

  • store at 59º to 77ºF in a dry place. Protect from heat, humidity, and light.
  • do not use if carton is open or if blister seal is ripped or broken  
  • see side panel for lot number and expiration date

Inactive ingredients

gelatin, glycerine, ink white, polyethylene glycol 400, purified water, sorbitol sorbitan solution  

Questions or comments?

call 1-800-706-5575

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Dye-Free Allergy LIQUI-GELS®.

MADE IN CANADA

Principal Display Panel

OTC Medicine

Allergy Relief

Diphenhydramine HCl

25 mg

24 Liquid Softgel Capsules

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6415
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
GELATIN 
POLYETHYLENE GLYCOL 400 
WATER 
SORBITOL 
Product Characteristics
ColorWHITE (Clear) Scoreno score
ShapeOCTAGON (8 sided)Size15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-6415-82 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2016
Labeler - Rite Aid Corporation (014578892)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited248441727analysis(11822-6415), manufacture(11822-6415)
Establishment
NameAddressID/FEIOperations
Catalent Ontario Limited243944050analysis(11822-6415), manufacture(11822-6415)
Establishment
NameAddressID/FEIOperations
Wanbury Limited650449981api manufacture(11822-6415)

Revised: 12/2017
 
Rite Aid Corporation

← See all Diphenhydramine Hydrochloride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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