Label: MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH- acetaminophen, guaifenesin tablet, film coated
- NDC Code(s): 72854-208-02, 72854-208-08, 72854-208-10, 72854-208-20
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 13, 2025
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH
acetaminophen, guaifenesin tablet, film coatedProduct 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)

