Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu

Generic name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Triprolidine Hydrochloride

RB Health (US) LLC

Dosage Form

N/A

Manufacturer

RB Health (US) LLC

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

do not use more than directed
excitability may occur, especially in children (Nightshift Cold & Flu only)
marked drowsiness may occur (Nightshift Cold & Flu only)
alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only)
avoid alcoholic drinks (Nightshift Cold & Flu only)
use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only)

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

63824-019-66
63824-503-66
72854-165-26

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

MUCINEX FAST-MAX DM MAX

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

MUCINEX NIGHTSHIFT COLD & FLU

temporarily relieves these common cold and flu symptoms:
- cough
- minor aches and pains
- sore throat
- headache
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes due to hay fever
temporarily reduces fever
controls cough to help you get to sleep

Liver warning (Nightshift Cold & Flu only)

This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4000 mg 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 (Nightshift Cold & Flu 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 (Nightshift Cold & Flu 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.

Overdose warning (Nightshift Cold & Flu only)

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

MUCINEX FAST-MAX DM MAX

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

MUCINEX NIGHTSHIFT COLD & FLU

do not take more than directed (see Overdose warning)
do not take more than 4 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

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

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Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.

Do not use if…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…pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only) fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only) redness or swelling is present (Nightshift Cold & Flu only) new symp…

Ask a doctor or pharmacist before use if…taking the blood thinning drug warfarin (Nightshift Cold & Flu only) taking sedatives or tranquilizers (Nightshift Cold & Flu only)

Stop use and talk to a doctor if…with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nightshift Cold & Flu only) if you are now taking a…

Storage and handlingeach 20 mL contains: sodium 12 mg (Fast-Max DM Max only) and sodium 16 mg (Nightshift Cold & Flu only) store at 20-25°C (68-77°F) do not refrigerate

Package labelDAY & NIGHT COUGH & COLD RELIEF MAXIMUM STRENGTH NDC 72854-165-26 Mucinex® FAST-MAX ® DM MAX Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant Controls Cough Relieves Chest Congestion Thins & Loosens Muc…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

MUCINEX FAST-MAX DM MAX

MUCINEX NIGHTSHIFT COLD & FLU

Liver warning (Nightshift Cold & Flu only)

Allergy alert (Nightshift Cold & Flu only)

Sore throat warning (Nightshift Cold & Flu only)

Overdose warning (Nightshift Cold & Flu only)

MUCINEX FAST-MAX DM MAX

MUCINEX NIGHTSHIFT COLD & FLU

SPL UNCLASSIFIED SECTION

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