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Allergy Relief Antihistamine by PLD Acquisitions LLC DBA Avéma Pharma Solutions

Medically reviewed on March 22, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: PLD Acquisitions LLC DBA Avéma Pharma Solutions
NDC Code: 63548-0690

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 tablet)

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 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 or as directed by a doctor
  • do not take more than 6 doses in 24 hours
 adults and children 12 years and overtake 1 to 2 tablets 
 children 6 to under 12 yearstake 1 tablet
children under 6 years do not use 

Other information
  • each tablet contains: calcium 25 mg
  • store between 20-25°C (68-77°F)
  • protect from light and moisture

Inactive ingredients

croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Principal Display Panel

Compare to the active ingredient in Benadryl® Allergy**

Allergy Relief

Diphenhydramine HCl 25 mg • Antihistamine

Relieves

  • Runny Nose
  • Sneezing
  • Itchy,Watery Eyes
  • Itchy Nose or Throat

Tablets

**This product is not manufactured or distributed by McNeil Consumer Healthcare,distributor of Benadryl ® Allergy

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Allergy Relief

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0690
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint CodeV;25
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-0690-11000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/02/2010
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

← See all Allergy Relief Antihistamine 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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