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Diphenhydramine Hydrochloride by Aurohealth LLC

Medically reviewed on March 1, 2018

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Aurohealth LLC
NDC Code: 58602-742

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 Tablets

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCl, USP 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 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 times in 24 hours

adults and children
12 years and over
1 to 2 tablets
children 6 to under 12 years
1 tablet
children under 6 years
do not use

Other information
  • each tablet contains: calcium 10 mg
  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if carton is opened, or seal under cap is torn or missing.

Inactive ingredients

colloidal silicon dioxide, crospovidone, D&C red no. 27 aluminium lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, titanium dioxide

Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allerg Ultra Tabs.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg Container Carton (24's Tablets)

AUROHEALTH

NDC 58602-742-07
*Compare to the
active ingredient in
Benadryl®Ultra tabs

Allergy Relief
Aurodryl
Diphenhydramine
Hydrochloride
25 mg Mini Tablets
Antihistamine

Relieves

  • Sneezing
  • Runny nose
  • Itchy, Watery Eyes
  • Itchy Throat

24
Mini Tablets






DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-742
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STARCH, CORN 
WATER 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULE (Biconvex) Size11mm
FlavorImprint CodeT;94
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-742-071 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
2NDC:58602-742-111 BOTTLE in 1 CARTON
236 TABLET, FILM COATED in 1 BOTTLE
3NDC:58602-742-131 BOTTLE in 1 CARTON
348 TABLET, FILM COATED in 1 BOTTLE
4NDC:58602-742-211 BOTTLE in 1 CARTON
4100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-742)

 
Aurohealth LLC

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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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