MUCINEX FAST-MAX COLD AND FLU- acetaminophen, dextromethorphan hydrobromide tablet

Mucinex Fast-Max Cold and Flu by

Drug Labeling and Warnings

Mucinex Fast-Max Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Acetaminophen 325 mg...Pain reliever/fever reducer
Dextromethorphan HBr 10 mg...Cough suppressant

Uses

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ 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
■ minor aches and pains
■ sore throat

■ headache
■ temporarily reduces fever

WARNINGS

Warnings
Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the
maximum daily amount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily while using this
product

Allergy alert: 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: 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.
■ 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
■ persistent or chronic cough such as occurs with
smoking, asthma, 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
When using this product do not use more than
directed

Stop use and ask a doctor if
■ pain or cough gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
■ 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.

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

Directions
■ do not take more than directed (see Overdose
warning)
■ do not take more than 12 caplets in any 24-hour
period
■ adults and children 12 years of age and over:
take 2 caplets every 4 hours
■ children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information
■ store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients
croscarmellose sodium, FD&C red no. 40 aluminum
lake, FD&C yellow no. 6 aluminum lake,
microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol, povidone, talc, titanium dioxide

QUESTIONS

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Acetaminophen » Pain Reliever/Fever Reducer
Dextromethorphan HBr » Cough Suppressant

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCINEX FAST-MAX COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-161
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	Chevron
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-161-10	1 in 1 CARTON	04/01/2025
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72854-161-20	2 in 1 CARTON	04/01/2025
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 72854-161-02	2 in 1 POUCH; Type 0: Not a Combination Product	04/01/2025
4	NDC: 72854-161-04	2 in 1 CARTON	04/01/2025
4		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/01/2025

Labeler - RB Health (US) LLC (081049410)