Axiv - Vrozzz Capsule, Liquid Filled
FDA Label NDC 82706-014

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Axiv - Vrozzz (NDC 82706-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Other

Drug Facts

This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS ZzzQuil Nighttime Sleep-Aid LiquidCaps.

Distributed by: Vivunt Pharma LLC

8590 w 74TH Court, Suite 1901

Miami, FL 33156-3178

Made in India

www.vivunt.live

Otc - Active Ingredient

Diphenhydramine HCl 50 mg

Otc - Purpose

Active Ingredient (in each softgel)	Purpose
Diphenhydramine HCl 25 mg	Nighttime Sleep-Aid

Uses

For the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Do Not Use

for children under 12 years of age
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
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

avoid alcoholic beverages

Stop Use And Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only 2 softgels per day (24 hours)

adults & children 12 years and over	take 2 softgels at bedtime if needed, or as directed by a doctor
children under 12 years	do not use

Other Information

store between 20-25°C (68-77 °F)
tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide.

Principal Display Panel

Compare to VICKS ZzzQuil

Nighttime Sleep-Aid LiquidCaps active ingredient*

NDC 82706-014-01

AXIV - VroZzz

Sleep Aid

For Nighttime Use

Fast Acting

Non-habit Forming

Diphenhydramine HCl

72 Softgels** **Liquid-filled capsules

* Please review the disclaimer below.

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