Axiv Vrozzz - Softgels

SPL v5

SPL

SPL Set ID 131a60cf-02ec-5a5b-e063-6294a90abd1f

Route

ORAL

Published

Effective Date 2023-08-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Methylparaben Polyethylene Glycol 400 Propylparaben Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AXIV Shape: oval Color: purple Size: 22 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-07

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 55105-1

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

Section 55106-9

Diphenhydramine HCl

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

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

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.

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

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.

Keep Out of Reach of Children

Keep out of reach of children.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Diphenhydramine HCl

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

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Overdose Warning (Overdose warning)

Other Information (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 (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 (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

When Using This Product (When using this product)

avoid alcoholic beverages

Stop Use and Ask A Doctor If (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.

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

Keep out of reach of children.

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

ask a health professional before use.

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
difficulty in urination due to enlargement of the 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

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Drug Facts", "55105-1": "Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Nighttime Sleep-Aid", "55106-9": "Diphenhydramine HCl", "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", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "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.", "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", "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.", "Keep out of reach of children": "Keep out of reach of children.", "If pregnant or breast-feeding,": "ask a health professional before use.", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:01.414209 · Updated: 2026-03-14T23:10:11.873456