MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH- acetaminophen, guaifenesin tablet, film coated

Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough by

Drug Labeling and Warnings

Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough 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

ACTIVE INGREDIENT

Active ingredients
(in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg

INDICATIONS & USAGE

Uses
■ temporarily relieves these common cold and flu
symptoms:
■ minor aches and pains ■ headache
■ sore throat
■ helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial
passageways of bothersome mucus and make
coughs more productive
■ 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.

Ask a doctor before use if you have
■ liver disease
■ 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
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.

DOSAGE & ADMINISTRATION

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, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, talc, titanium dioxide

QUESTIONS

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

PURPOSE

Acetaminophen 325 mg ........ Pain reliever/
fever reducer
Guaifenesin 200 mg.................... Expectorant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH 
acetaminophen, guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72854-208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	VVV;MSC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72854-208-10	1 in 1 CARTON	05/01/2025
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72854-208-20	2 in 1 CARTON	05/01/2025
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 72854-208-02	2 in 1 POUCH; Type 0: Not a Combination Product	05/01/2025
4	NDC: 72854-208-08	4 in 1 CARTON	05/01/2025
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	05/01/2025

Labeler - RB Health (US) LLC (081049410)