MedPath

AXIM DayTime - Night Time 48 Softgels

AXIM DayTime & Night Time

Approved
Approval ID

de9eb2d5-ba51-4637-e053-2995a90a0451

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

VIVUNT PHARMA LLC

DUNS: 045829437

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82706-003
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Product Specifications
Effective DateAugust 20, 2025
FDA Product Classification

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82706-004
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Product Specifications
Effective DateAugust 20, 2025
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/9/2022

PRINCIPAL DISPLAY PANEL - 72 Caps Day&Night

Compare to Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®

active ingredients*

NDC 82706-004-01

Day Time

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

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl

48 SOFTGELS****Liquid-filled capsules

Night Time

  • Pain Reliever
  • Fever Reducer
  • Cough Suppressant
  • Antihistamine

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

24 SOFTGELS****Liquid-filled capsules

*This product is not manufactured or distributed by The Procter & Gamble

Company, owner of the registered trademarks Vicks® DayQuil ® & NyQuil ®

Cold&Flu LiquiCaps®.

AXIM DayTime Night Time 72 caps

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/9/2022

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/9/2022

Product of India

Distributed by:

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

Miami, Florida. Z,C. 33156-3178

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/9/2022

Active ingredients (in each softgel)

Purpose

Acetaminophen 325 mg

Pain reliever/fever reducer

Dextromethorphan HBr 15 mg

Cough suppressant

Doxylamine succinate 6.25 mg

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/9/2022

Warnings

Liver warning

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

  • more than 4000 mg of acetaminophen in 24 hours.
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert

Allergy alert: 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

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

  • 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
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • 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.

These could be signs of a serious condition.

Keep out of reach of children.

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning

Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/9/2022

Directions

  • Take only as directed (see overdose warning):
  • Do not take more than 8 softgels in 24 hours.

adults and children over 12 years

2 softgels with water every 6 hours

children 4 to under 12 years

consult a doctor

children under 4 years

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/9/2022

Other information

  • 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/9/2022

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

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