Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough
350764de-7801-b24e-e063-6394a90ab3c3
HUMAN OTC DRUG LABEL
May 13, 2025
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
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
WARNINGS SECTION
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
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 SECTION
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
Questions? 1-866-MUCINEX
(1-866-682-4639)
OTC - PURPOSE SECTION
Acetaminophen 325 mg ........ Pain reliever/
fever reducer
Guaifenesin 200 mg.................... Expectorant
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.