MedPath

Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough

Approved
Approval ID

350764de-7801-b24e-e063-6394a90ab3c3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 13, 2025

Manufacturers
FDA

RB Health (US) LLC

DUNS: 081049410

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72854-208
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2025
FDA Product Classification

INGREDIENTS (12)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
GUAIFENESINActive
Quantity: 200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/1/2025

carton label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/1/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/1/2025

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/1/2025

Active ingredients
(in each caplet)

Acetaminophen 325 mg
Guaifenesin 200 mg

WARNINGS SECTION

LOINC: 34071-1Updated: 5/1/2025

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 SECTION

LOINC: 34068-7Updated: 5/1/2025

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

LOINC: 60561-8Updated: 5/1/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/1/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/1/2025

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/1/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/1/2025

Keep out of reach of children.

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