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

Description

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

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 55106-9

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Section 60561-8

Other information

■ each 20 mL contains: sodium 9 mg

■ store at 20-25°C (68-77°F)

■ do not refrigerate

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.

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


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

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 55106-9 (55106-9)

Active ingredients

(in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

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

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.

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


Advanced Ingredient Data


Raw Label Data

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