Axiv Night Time Cold & Flu - Liquid

Axiv Night Time Cold & Flu - Liquid
SPL v4
SPL
SPL Set ID 186f8519-655d-bd21-e063-6294a90a16a8
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 (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
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:

  • sore throat
  • minor aches & pains
  • runny nose & sneezing
  • headache
  • fever
  • cough due to minor throat & 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 30 mg Cough suppressant
Doxylamine succinate 12.5 mg Antihistamine
Warnings

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, limit total to 4 doses per 24 hours
adults and children 12 years and over 30 mL every 6 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
  • to make a child sleep
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:

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

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control 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

Other Information
  • Each 30 mL dose cup contains: sodium 10 mg
  • Store at room temperature 15 - 30°C (59 - 89°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 Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel

Compare to VICKS ®NyQuil ®

Cold & Flu active ingredients*

NDC 82706-023-01

AXIV - NightTime

COLD&FLU

Multi-Symptom Relief

  • Pain Reliever
  • Fever Reducer
  • Cough Suppresant
  • Antihistamine

Nighttime Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

12 FL OZ (355 mL)

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

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.

If Pregnant Or Breast Feeding

ask a health professional before use.

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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • sore throat
  • minor aches & pains
  • runny nose & sneezing
  • headache
  • fever
  • cough due to minor throat & 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 30 mg Cough suppressant
Doxylamine succinate 12.5 mg Antihistamine
Warnings

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, limit total to 4 doses per 24 hours
adults and children 12 years and over 30 mL every 6 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
  • to make a child sleep
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:

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

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control 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

Other Information (Other information)
  • Each 30 mL dose cup contains: sodium 10 mg
  • Store at room temperature 15 - 30°C (59 - 89°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 Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to VICKS ®NyQuil ®

Cold & Flu active ingredients*

NDC 82706-023-01

AXIV - NightTime

COLD&FLU

Multi-Symptom Relief

  • Pain Reliever
  • Fever Reducer
  • Cough Suppresant
  • Antihistamine

Nighttime Relief

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

12 FL OZ (355 mL)

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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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