FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Tablets

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2020-12-04
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:04:01

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Diphenhydramine HCl, USP 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-74258602-742-07, 58602-742-11, 58602-742-13, 58602-742-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 272LRS185U6KIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ab9202e-1263-d166-e063-6294a90a8891eca90b31-3bb5-40d4-8e87-ad3fcd74f8872023-11-22WarningsExact identifier
spl set id: eca90b31-3bb5-40d4-8e87-ad3fcd74f887

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.