axiv allergy relief

axiv allergy relief
SPL v4
SPL
SPL Set ID 1323a67c-b9c5-038c-e063-6394a90a5e6b
Route
oral
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
propylparaben gelatin methylparaben water glycerin sorbitol polyethylene glycol 400 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-03-08 Until 2024-03-09

Description

Drug Facts


Medication Information

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
Directions
  • 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 children 12 years and over. Do not take more than 6 Softgels for children 6 to under 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
Other Information
  • 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.
  • Tamper Evident: Do not use if carton or pouch is open
Inactive Ingredients

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 55105-1
Active Ingredient (in each softgel) Purpose
Diphenhydramine HCl 25 mg Antihistamine

Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Overdose Warning

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

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
Allergy Relief 50 Softgels

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-03

AXIV Antihistamine

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

DYE-FREE

Diphenhydramine HCl

50 SOFTGELS** **Liquid-filled capsules

Principal Display Panel 24

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-01

AXIV Antihistamine

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

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Distributed By: Vivunt Pharma Llc

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178

Made in India.

www.vivunt.live

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


Structured Label Content

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
Directions
  • 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 children 12 years and over. Do not take more than 6 Softgels for children 6 to under 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
Other Information (Other information)
  • 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.
  • Tamper Evident: Do not use if carton or pouch is open
Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)
Active Ingredient (in each softgel) Purpose
Diphenhydramine HCl 25 mg Antihistamine

Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Overdose Warning

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

When Using This Product (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
Allergy Relief 50 Softgels (Allergy Relief 50 softgels)

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-03

AXIV Antihistamine

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

DYE-FREE

Diphenhydramine HCl

50 SOFTGELS** **Liquid-filled capsules

Principal Display Panel 24 (PRINCIPAL DISPLAY PANEL 24)

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC 82706-019-01

AXIV Antihistamine

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

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Distributed By: Vivunt Pharma Llc (Distributed by: VIVUNT PHARMA LLC)

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178

Made in India.

www.vivunt.live

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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