Axiv - Daytime Cold & Flu - Liquid

Axiv - Daytime Cold & Flu - Liquid
SPL v5
SPL
SPL Set ID 1872e1ff-2e08-c404-e063-6294a90afa14
Route
ORAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Fd&c Yellow No. 6 Menthol, Unspecified Form Water Sodium Benzoate Propylene Glycol Sucralose Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-14

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

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

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Directions
  • take only as directed (see overdose warning)
  • measure only with dosage cup provided and keep dosage cup with product
  • mL = milliliter
  • do not exceed 4 doses per 24 hours
  • when using DayTime and NightTime products, carefully read each label to ensure correct dosing

adults and children 12 years and over 30 mL every 4 hours
children under 12 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

  • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Overdose Warning

Taking more than the recommended dose (overdose) could cause seriuos health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • Each 30 mL dose cup contains: sodium 10 mg
  • Store at room temperature 15 - 30°C (59 - 86°F) and do not refrigerate
  • Tamper evident: Do not use if shrink band is missing or broken
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

Citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Principal Display Panel

Compare to

VICKS ® DayQuil®

Cold&Flu active ingredients*

NDC 82706-022-01

AXIV - DayTime

COLD&FLU

Multi-Symptom Relief

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

Non-Drowsy

Acetaminophen, Dextromethorphan HBr

12 FL OZ (355 mL)

*This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®.

When Using This Product

do not use more than directed (see overdose warning)

Stop Use and Ask A Doctor If
  • 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

If Pregnant Or Breast Feeding

ask a health professional before use.

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

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

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)
Active ingredients (in each 30 mL dose cup) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Directions
  • take only as directed (see overdose warning)
  • measure only with dosage cup provided and keep dosage cup with product
  • mL = milliliter
  • do not exceed 4 doses per 24 hours
  • when using DayTime and NightTime products, carefully read each label to ensure correct dosing

adults and children 12 years and over 30 mL every 4 hours
children under 12 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

  • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) could cause seriuos health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • Each 30 mL dose cup contains: sodium 10 mg
  • Store at room temperature 15 - 30°C (59 - 86°F) and do not refrigerate
  • Tamper evident: Do not use if shrink band is missing or broken
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)

Citric acid, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to

VICKS ® DayQuil®

Cold&Flu active ingredients*

NDC 82706-022-01

AXIV - DayTime

COLD&FLU

Multi-Symptom Relief

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

Non-Drowsy

Acetaminophen, Dextromethorphan HBr

12 FL OZ (355 mL)

*This product is not manufactured or distributed by The Procter &Gamble Company, owner of the registered trademarks Vicks® DayQuil®.

When Using This Product (When using this product)

do not use more than directed (see overdose warning)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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

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

ask a health professional before use.

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)