AXIV - VroZzz DIPHENHYDRAMINE HYDROCHLORIDE VIVUNT PHARMA LLC FDA Approved Uses For the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
FunFoxMeds box
Route
ORAL
Applications
M010
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Diphenhydramine HCl Active Ingredient (in each softgel) Purpose Diphenhydramine HCl 25 mg Nighttime Sleep-Aid
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.
Strengths
25 mg
Treats Conditions
Uses For The Relief Of Occasional Sleeplessness Reduces Time To Fall Asleep If You Have Difficulty Falling Asleep
Pill Appearance
Shape: oval Color: purple Imprint: AXIV

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0850047780614
UNII
TC2D6JAD40
Packaging

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 72

Package Descriptions
  • 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 72

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings 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.
Purpose

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

Do Not Use

Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

When Using

When using this product avoid alcoholic beverages

Stop Use & Ask a Doctor

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.

Storage & Handling

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.


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