Axiv Nighttime Cold & Flu

Axiv Nighttime Cold & Flu
SPL v5
SPL
SPL Set ID 131f6314-c9a1-7af3-e063-6294a90abe6f
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Propylparaben D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide Methylparaben

Identifiers & Packaging

Pill Appearance
Imprint: AXIV Shape: oval Color: green 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 & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
Section 42229-5

Drug Facts

Section 55105-1
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

Directions
  • Take only as directed (see overdose warning)
  • Do not take more than 8 Softgels in 24 hours

adults & children 12 years and over 2 Softgels with water every 6 hrs
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
  • 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 you take

  • more than 8 Softgels 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

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
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper Evident: Do not use if carton is open
  • Tamper Evident: Do not use if carton or blister 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

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

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
Principal Display Panel 24

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-01

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

24 Softgels** **Liquid-filled capsules

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 the Reach of Children

Keep out of reach of children.

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
Principal Display Panel 50 Softgels

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-04

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

50 Softgels** **Liquid-filled capsules

Package Label Principal Display Panel 100

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-03

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

100 Softgels** **Liquid-filled capsules

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
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 15 mg Cough suppressant
Doxylamine succinate 6.25 mg Antihistamine
Warnings

Directions
  • Take only as directed (see overdose warning)
  • Do not take more than 8 Softgels in 24 hours

adults & children 12 years and over 2 Softgels with water every 6 hrs
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
  • 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 you take

  • more than 8 Softgels 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)

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)
  • Store at 20° - 25 °C (68 °- 77 °F)
  • Read all product information before using
  • Tamper Evident: Do not use if carton is open
  • Tamper Evident: Do not use if carton or blister 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)

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

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
Principal Display Panel 24 (PRINCIPAL DISPLAY PANEL 24)

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-01

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

24 Softgels** **Liquid-filled capsules

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 the Reach of Children (Keep out of the 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
  • 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
Principal Display Panel 50 Softgels (Principal display panel 50 softgels)

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-04

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

50 Softgels** **Liquid-filled capsules

Package Label Principal Display Panel 100 (PACKAGE LABEL PRINCIPAL DISPLAY PANEL 100)

Compare to VICKS ®NyQuil ®

Cold & Flu LiquiCaps®

active ingredients*

NDC 82706-016-03

AXIV NightTime Cold & Flu

Multi-Symptom Relief

Pain Reliever

Fever Reducer

Cough Suppresant

Antihistamine

Nighttime Relief

Acetaminophen, Doxylamine Succinate , Dextromethorphan HBr

100 Softgels** **Liquid-filled capsules

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
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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