AXIM DayTime

Manufacturer
VIVUNT PHARMA LLC
Effective date
2024-06-14
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:00:41

Label at a glance#

ProductAXIM DayTime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: nasal Congestion 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.

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
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • nasal Congestion
  • 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 4,000 mg of acetaminophen in 24 hours
  • 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
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • 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

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.

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

Product of India

Distributed by:

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

Miami, Florida. Z,C. 33156-3178

PRINCIPAL DISPLAY PANEL - Axim DayTime Carton 24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to

VICKS ® DayQuil®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-001-01

AXIM - DayTime

COLD&FLU

Multi-Symptom Relief

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


Non-Drowsy

Acetaminophen , Phenylephrine HCl,

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®.

AXIM Day TimeAXIM Day Time

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-001AXIM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC]10Legacy NDC20240616_de9f3bcf-9622-e78c-e053-2a95a90a8662.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-00182706-001-01, 82706-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
3ccdb45b-e7e5-87ec-e063-6294a90aa58ede9f3bcf-9622-e78c-e053-2a95a90a86622025-08-20WarningsExact identifier
spl set id: de9f3bcf-9622-e78c-e053-2a95a90a8662

Reported adverse events (FAERS/openFDA)#

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