Axiv - Daytime Cold & Flu

Axiv - Daytime Cold & Flu
SPL v4
SPL
SPL Set ID 131b1f17-cd86-f9b3-e063-6294a90a3028
Route
ORAL
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Methylparaben Glycerin Fd&c Yellow No. 6 Fd&c Red No. 40 Gelatin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Propylparaben Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: orange Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-07 Until 2024-03-07
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5

Drug Facts

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg Cough Suppressant
Directions
  • 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
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
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

Liver Warning

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
Overdose Warning

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

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.
  • Tamper evident: Do not use if carton or pouch is open
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.

Inactive Ingredients

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

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®.

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®.

When Using This Product

do not exceed recommended dose

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Ask A Doctor Before Use If You Have
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
Section 42229-5 (42229-5)

Drug Facts

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain Reliever/Fever Reducer
Dextromethorphan HBr 10 mg Cough Suppressant
Directions
  • 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
Do Not Use (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
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

Liver Warning (Liver warning)

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
Overdose Warning (Overdose warning)

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

Other Information (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.
  • Tamper evident: Do not use if carton or pouch is open
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (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®.

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®.

When Using This Product (When using this product)

do not exceed recommended dose

Stop Use and Ask A Doctor If (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

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

ask a health professional before use.

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

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:33.262968 · Updated: 2026-03-14T23:07:31.529158