Axiv Dm Max - Liquid

Axiv Dm Max - Liquid
SPL v1
SPL
SPL Set ID 18704e66-ee8f-315d-e063-6294a90a5282
Route
ORAL
Published
Effective Date 2024-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Propylene Glycol Citric Acid Monohydrate Fd&c Red No. 40 Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum Water Glycerin Fd&c Blue No. 1

Identifiers & Packaging

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

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
Section 42229-5

Drug Facts

Section 50567-7

Do not exceed recommended dosage.

Section 55105-1
Active ingredients (in each 20 mL) Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 12 years of age do not use

Do Not Use
  • 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.
Other Information
  • each 20 mL contains: sodium 7 mg
  • store at 15-30°C (59-86°F)
  • do not refrigerate
Inactive Ingredients

Citric acid, FD&C Blue #1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Principal Display Panel

Compare to Maximum Strength Mucinex® Fast-Max®

NDC 82706-024-01

AXIV - DM MAX

Cough Relief

Cough Suppressant

Expectorant

Maximum Strength

Non-Drowsy

Dextromethorphan HBr

Guaifenesin

6 FL OZ (177 mL)

Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep
Section 42229-5 (42229-5)

Drug Facts

Section 50567-7 (50567-7)

Do not exceed recommended dosage.

Section 55105-1 (55105-1)
Active ingredients (in each 20 mL) Purposes
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • this adult strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 12 years of age do not use

Do Not Use (Do not use)
  • 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.
Other Information (Other information)
  • each 20 mL contains: sodium 7 mg
  • store at 15-30°C (59-86°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C Blue #1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to Maximum Strength Mucinex® Fast-Max®

NDC 82706-024-01

AXIV - DM MAX

Cough Relief

Cough Suppressant

Expectorant

Maximum Strength

Non-Drowsy

Dextromethorphan HBr

Guaifenesin

6 FL OZ (177 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, 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.)

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Advanced Ingredient Data


Raw Label Data

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