Diphenhydramine hydrochloride tablet, film coated

Drug facts

Active ingredient (in each tablet)

Diphenhydramine HCl, USP25 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 anenlarged prostate gland

Ask a doctor or pharmacist before use if you aretaking 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 inchildren

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 under6 years
do not use

Other information

  • each tablet contains: calcium 10 mg
  • store between 20-25C (68-77F). 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

Ingredients and appearance - Product information

Diphenhydramine hydrochloride tablet, film coated- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-742
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Crospovidone (120 .mu.m) ( UNII: 68401960MK)
D&c red no. 27 ( UNII: 2LRS185U6K)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Starch, corn ( UNII: O8232NY3SJ)
Water ( UNII: 059QF0KO0R)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color PINK Shape CAPSULE (Biconvex)
Size 11 mm Score 1
Imprint Code T;94

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-742)

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