Mucinex Fast-max Severe Congestion & Cough

Mucinex Fast-max Severe Congestion & Cough
SPL v2
SPL
SPL Set ID 14be3ab0-d6ae-e342-e063-6294a90ab851
Route
ORAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Povidone Water Glycerin Hypromelloses Polyethylene Glycol, Unspecified Fd&c Blue No. 1 D&c Yellow No. 10 Lecithin, Soybean Light Mineral Oil Propylene Glycol Gelatin Titanium Dioxide Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: AR08 Shape: oval Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Active ingredients (in each liquid gel) Purposes Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant


Medication Information

Warnings and Precautions

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.

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)

When using this product do not use more than directed

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.

Description

Active ingredients (in each liquid gel) Purposes Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant

Uses

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 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive ingredients

D&C yellow no.10, FD&C blue no. 1, gelatin,

glycerin, hypromellose, lecithin, light mineral oil,

polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol sorbitan solution, titanium

dioxide

Section 51945-4

Fast Dissolving Liquid Gels!

NDC 72854-153

MAXIMUM STRENGTH

MUCINEX®

FAST-MAX ®

Section 53413-1

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1

Dextromethorphan HBr 10 mg....Cough suppressant

Guaifenesin 200mg...............................Expectorant

Section 55106-9
Active ingredients (in each liquid gel) Purposes
Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg Expectorant

Section 60561-8

■ store at 20-25°C (68-77°F)

■ avoid excessive heat

Directions

■ do not take more than 12 capsules in any

24-hour period

■ adults and children 12 years of age and over:

take 2 capsules every 4 hours

■ children under 12 years of age: do not use


Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

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.

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)

When using this product do not use more than directed

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

D&C yellow no.10, FD&C blue no. 1, gelatin,

glycerin, hypromellose, lecithin, light mineral oil,

polyethylene glycol, povidone, propylene glycol,

purified water, sorbitol sorbitan solution, titanium

dioxide

Section 51945-4 (51945-4)

Fast Dissolving Liquid Gels!

NDC 72854-153

MAXIMUM STRENGTH

MUCINEX®

FAST-MAX ®

Section 53413-1 (53413-1)

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1 (55105-1)

Dextromethorphan HBr 10 mg....Cough suppressant

Guaifenesin 200mg...............................Expectorant

Section 55106-9 (55106-9)
Active ingredients (in each liquid gel) Purposes
Dextromethorphan HBr 10 mg

Cough suppressant

Guaifenesin 200 mg Expectorant

Section 60561-8 (60561-8)

■ store at 20-25°C (68-77°F)

■ avoid excessive heat

Directions

■ do not take more than 12 capsules in any

24-hour period

■ adults and children 12 years of age and over:

take 2 capsules every 4 hours

■ children under 12 years of age: do not use


Advanced Ingredient Data


Raw Label Data

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