AXIV Allergy Relief

Manufacturer
VIVUNT PHARMA LLC
Effective date
2024-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:38

Label at a glance#

ProductAXIV Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Temporarily relieves these symptoms due to have fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose 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 12 caplets in 24 hours for adults and children 12 years and over. Do not take more than 6 caplets for children 6 to under 12 years of age in 24 hours adults and children 12 years and over 1 or 2 caplets children 6 to under 12 years 1 caplet children under 6 years do not use

Storage and handling

Store at 20°-25°C (68°-77°F) Read all product information before using Tamper evident: Do not use if carton or pouch is open.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingrediente (in each caplet) --------------- Purpose

Diphenhydramine HCl 25 mg ------------------------- Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to have fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose throat
  • temporarily relieves these symptoms due to the common cold:
  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleep
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professinal before use.

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours, or as directed by a doctor

do not take more than 12 caplets in 24 hours for adults and children 12 years and over. Do not take more than 6 caplets for children 6 to under 12 years of age in 24 hours

  • adults and children 12 years and over 1 or 2 caplets
  • children 6 to under 12 years 1 caplet
  • children under 6 years do not use

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°-25°C (68°-77°F)
  • Read all product information before using
  • Tamper evident: Do not use if carton or pouch is open.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Cellulose, Dibasic Calcium Phosphate, D&C Red #27, Magnesium Stereate, Microcrystalline, Phloxine Aluminium Lake, Polyethylene Glycol, Polyvinyl Alcohol, Silicon Dioxide, Talc, Titanium Dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredient*

NDC 82706-021-02

AXIV Allergy Relief

Antihistamine

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

Diphenhydramine HCl

100 CAPLETS

Allergy Relief 100Allergy Relief 100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-021-02AXIV Allergy Relief50 in 1 CARTONTABLET501
82706-021-02AXIV Allergy Relief2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-021AXIV ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VIVUNT PHARMA LLC]1Current NDC, 2 package rows20240720_1cd2a6f1-31ad-e507-e063-6394a90aba58.zip

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
82706-02182706-021-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
AXIV Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVIVUNT PHARMA LLC1cd2a6f1-31ad-e507-e063-6394a90aba582024-07-09WarningsExact identifier
ndc (package): 82706-021-02
ndc (product): 82706-021
ndc11 (package): 82706002102
spl id: 1cd2a6f1-31ae-e507-e063-6394a90aba58
spl set id: 1cd2a6f1-31ad-e507-e063-6394a90aba58

Reported adverse events (FAERS/openFDA)#

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