mucinex fast-max kickstart severe congestion & cough

mucinex fast-max kickstart severe congestion & cough
SPL v1
SPL
SPL Set ID 19105007-0193-0764-e063-6294a90a01a4
Route
oral
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg) dextromethorphan (20 mg)
Inactive Ingredients
sodium benzoate sorbitol water xanthan gum d&c yellow no. 10 propylene glycol edetate disodium sucralose anhydrous citric acid ammonium glycyrrhizate fd&c blue no. 1 trisodium citrate dihydrate glycerin

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2024-08-15

Description

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Warnings

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.

Active Ingredient

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

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

Directions

Directions

■ do not take more than 6 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over:

20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Description

Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 50565-1

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 51727-6

Inactive ingredients

ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow

no. 10, edetate disodium, FD&C blue no. 1, flavor,

glycerin (soy), propylene glycol, purified water,

sodium benzoate, sorbitol, sucralose, trisodium

citrate dihydrate*, xanthan gum

*may contain this ingredient

Section 51945-4

NDC 72854-159-66

Relieves Chest Congestion

Controls Cough

Thins& Loosens Mucus

6 fl oz (180mL)

MENTHOL FLAVORED LIQUID

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Ages 12+

Section 53413-1

Questions?

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

Section 55105-1

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Section 60561-8

Other information

■ each 20 mL contains: sodium 9 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Structured Label Content

Warnings

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.

Active Ingredient (55106-9)

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

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

Directions

Directions

■ do not take more than 6 doses in any

24-hour period

■ measure only with dosing cup provided

■ do not use dosing cup with other products

■ dose as follows or as directed by a doctor

■ adults and children 12 years of age and over:

20 mL in dosing cup provided every 4 hours

■ children under 12 years of age: do not use

Section 50565-1 (50565-1)

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 51727-6 (51727-6)

Inactive ingredients

ammonium, glycyrrhizate, anhydrous citric acid, D&C yellow

no. 10, edetate disodium, FD&C blue no. 1, flavor,

glycerin (soy), propylene glycol, purified water,

sodium benzoate, sorbitol, sucralose, trisodium

citrate dihydrate*, xanthan gum

*may contain this ingredient

Section 51945-4 (51945-4)

NDC 72854-159-66

Relieves Chest Congestion

Controls Cough

Thins& Loosens Mucus

6 fl oz (180mL)

MENTHOL FLAVORED LIQUID

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Ages 12+

Section 53413-1 (53413-1)

Questions?

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

Section 55105-1 (55105-1)

Dextromethorphan HBr » Cough Suppressant

Guaifenesin » Expectorant

Section 60561-8 (60561-8)

Other information

■ each 20 mL contains: sodium 9 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate


Advanced Ingredient Data


Raw Label Data

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