FDA.reportPublic FDA data

AXIV DayTime

Manufacturer
VIVUNT PHARMA LLC
Effective date
2025-02-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:09

Label at a glance#

ProductAXIV DayTime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever

Dosage and administration

Take only as directed (see overdose warning) Do not take more than 8 softgels in 24 hours. adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 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 carton is open or blister unit is broken. Tamper evident: Do not use if carton or pouch is open

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain Reliever/Fever Reducer
Dextromethorphan HBr 10 mgCough Suppressant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 Softgels in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition

Keep out of reach of 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

SPL UNCLASSIFIED SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only as directed (see overdose warning)
  • Do not take more than 8 softgels in 24 hours.
adults and children 12 years and over2 softgels with water every 4 hours
children 4 to under 12 yearsconsult a doctor
children under 4 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 carton is open or blister unit is broken.
  • Tamper evident: Do not use if carton or pouch is open

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, FD&C Yellow No. 6, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

SPL UNCLASSIFIED SECTION


Distributed by:

VIVUNT PHARMA LLC
8950 SW 74th. Court. Suite 1901

Miami, Florida, 33156-3178

Made in India

www.vivunt.live

PRINCIPAL DISPLAY PANEL AXIV DayTime Carton 24 ​AXIV DayTime Carton 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to

VICKS ® DayQuil®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-015-01

AXIV - DayTime

COLD&FLU

Multi-Symptom Relief

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Nasal Decongestant


Non-Drowsy

Acetaminophen, Dextromethorphan HBr

24 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by

The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®

and LiquiCaps®.

AXIV1DAYAXIV1DAY

Compare to

VICKS ® DayQuil®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-015-03

AXIV - DayTime

COLD&FLU

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant


Non-Drowsy

Acetaminophen, Dextromethorphan HBr

100 SOFTGELS** **Liquid-filled capsules

*This product is not manufactured or distributed by

The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®

and LiquiCaps®.

Day Time AXIV 100 softgelsDay Time AXIV 100 softgels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsulePSN4
1867684acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral CapsuleSCD4
1867684acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral CapsuleSY4
1867684APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-015-01AXIV DayTime3 in 1 CARTONCAPSULE, LIQUID FILLED34
82706-015-01AXIV DayTime8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
82706-015-02AXIV DayTime2 in 1 POUCHCAPSULE, LIQUID FILLED24
82706-015-02AXIV DayTime2 in 1 CARTONCAPSULE, LIQUID FILLED24
82706-015-03AXIV DayTime2 in 1 POUCHCAPSULE, LIQUID FILLED24
82706-015-03AXIV DayTime50 in 1 CARTONCAPSULE, LIQUID FILLED504
82706-015-04AXIV DayTime25 in 1 BLISTER PACKCAPSULE, LIQUID FILLED254
82706-015-04AXIV DayTime25 in 1 CARTONCAPSULE, LIQUID FILLED254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-015AXIV DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]4Current NDC, 8 package rows20250215_131b1f17-cd86-f9b3-e063-6294a90a3028.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-01582706-015-01, 82706-015-02, 82706-015-03, 82706-015-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE K30U725QWY32XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
AXIV DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC131b1f17-cd86-f9b3-e063-6294a90a30282025-02-12WarningsExact identifier
ndc (package): 82706-015-02
ndc (package): 82706-015-01
ndc (package): 82706-015-04
ndc (package): 82706-015-03
ndc (product): 82706-015
ndc11 (package): 82706001504
ndc11 (package): 82706001501
ndc11 (package): 82706001502
ndc11 (package): 82706001503
spl id: 2df4babb-e0e7-5e06-e063-6294a90a8cc4
spl set id: 131b1f17-cd86-f9b3-e063-6294a90a3028

Reported adverse events (FAERS/openFDA)#

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