FDA.reportPublic FDA data

Axim Allergy

Manufacturer
VIVUNT LLC
Effective date
2024-06-06
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:01:05

Label at a glance#

ProductAxim Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 12 Softgels in 24 hours for Adults and do not take more than 6 Softgels for children 6 to 12 years of age in 24 hours. adults and children 12 years and over 1 or 2 Softgels children 6 to under 12 years 1 Softgel 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 the foil printed on the blister is torn or ripped.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient (in each softgel)Purpose
Diphenhydramine HCl 25 mgAntihistamine

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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 professional 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 Softgels in 24 hours for Adults and do not take more than 6 Softgels for children 6 to 12 years of age in 24 hours.
adults and children 12 years and over 1 or 2 Softgels
children 6 to under 12 years1 Softgel
children under 6 yearsdo 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 the foil printed on the blister is torn or ripped.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

PRINCIPAL DISPLAY PANEL 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-005-01

Antihistamine

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

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

Axim AllergyAxim Allergy

PRINCIPAL DISPLAY PANEL 6

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-005-02

Antihistamine

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat

DYE-FREE

Diphenhydramine HCl

6 SOFTGELS** **Liquid-filled capsules

AllergyAllergy

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-005AXIM ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VIVUNT LLC]10Legacy NDC20240608_de9eb2bf-7c32-558e-e053-2995a90a5c83.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-00582706-005-01, 82706-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
GELATIN2G86QN327LIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
3ccdebd7-941d-6538-e063-6394a90a9a3fde9eb2bf-7c32-558e-e053-2995a90a5c832025-08-20WarningsExact identifier
spl set id: de9eb2bf-7c32-558e-e053-2995a90a5c83

Reported adverse events (FAERS/openFDA)#

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