MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
RB Health (US) LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Phenylephrine HCl 10 mg | Nasal decongestant |
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
- nasal congestion due to a cold
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- 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
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- 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.
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 older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age:
do not use
Other information
- each 20 mL contains: sodium 9 mg
- store between 20-25°C (68-77°F)
- do not refrigerate
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum
1may contain this ingredientQuestions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
MAXIMUM STRENGTH
NDC 63824-540-66
Mucinex®
FAST-
MAX®SEVERE CONGESTION
& COUGH
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
6 FL OZ (180 mL)
FOR AGES 12+
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
- Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- temporarily relieves (DAY TIME only):
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- nasal congestion due to a cold
- temporarily helps you cough less
- temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- temporarily reduces fever (NIGHT TIME only)
- controls cough to help you get to sleep (NIGHT TIME only)
- Warnings
Liver warning (NIGHT TIME only)
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert (NIGHT TIME only)
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.
Sore throat warning (NIGHT TIME only)
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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. (NIGHT TIME only)
- with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
- 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
- liver disease (NIGHT TIME only)
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME only)
- breathing problems such as emphysema or chronic bronchitis (NIGHT TIME only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin (NIGHT TIME only)
- taking sedatives or tranquilizers (NIGHT TIME only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT TIME only)
- marked drowsiness may occur (NIGHT TIME only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
- avoid alcoholic drinks (NIGHT TIME only)
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever (DAY TIME only)
- pain, nasal congestion, or cough gets worse or lasts more than 7 days (NIGHT TIME only)
- fever gets worse or lasts more than 3 days (NIGHT TIME only)
- redness or swelling is present (NIGHT TIME only)
- new symptoms occur (NIGHT TIME only)
- 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 reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. 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.
- Directions
- do not take more than directed (see Overdose warning)
- 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 older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- each 20 mL contains: sodium 9 mg
- store between 20-25°C (68-77°F)
- dosing cup provided
- do not refrigerate
-
Inactive ingredients (Mucinex FAST-MAX Severe Congestion & Cough CLEAR & COOL)
anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum
-
Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu CLEAR & COOL)
anhydrous citric acid, D&C yellow no.10, edetate disodium, FD&C blue no.1, flavors, glycerin, propyl gallate, propylene glycol, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum
-
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number. - SPL UNCLASSIFIED SECTION
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224 - PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 63824-541-66
MAXIMUM STRENGTH
Mucinex®
FAST-MAX®SEVERE CONGESTION
& COUGHCLEAR & COOL™
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant✓ Controls Cough
✓ Relieves Nasal & Chest Congestion
✓ Thins & Loosens Mucus6 FL OZ (180mL)
FOR AGES 12+NDC 63824-510-66
MAXIMUM STRENGTH*
Mucinex®
FAST-MAX®NIGHT TIME
COLD & FLUCLEAR & COOL™
Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl - Antihistamine/Cough Suppressant
Phenylephrine HCl – Nasal Decongestant✓ Relieves Aches, Fever & Sore Throat
✓ Controls Cough
✓ Relieves Nasal Congestion
✓ Relieves Runny Nose & Sneezing6 FL OZ (180mL)
FOR AGES 12+