Label: MUCINEX FAST-MAX COLD, FLU AND SORE THROAT- acetaminophen, guaifenesin tablet
- NDC Code(s): 72854-162-20
- Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 20, 2026
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
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 older:
take 2 caplets every 4 hours - children under 12 years of age: do not use
-
KEEP OUT OF REACH OF CHILDREN
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.
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. -
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 directedStop 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 - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton
-
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD, FLU AND SORE THROAT
acetaminophen, guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape CAPSULE Size 19mm Flavor Imprint Code SC;Chevron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-162-20 2 in 1 CARTON 04/01/2025 1 10 in 1 BLISTER PACK; 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 - Reckitt Benckiser LLC (094405024)


