Label: MUCINEX FAST-MAX COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 72854-126-08, 72854-126-10, 72854-126-16
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 7, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- cough
- stuffy nose
- minor aches and pains
- sore throat
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phelegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these common cold and flu symptoms:
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- 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 (precription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a precription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your precription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistant or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and over: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton
Fast Dissolving Liquid Gels!
NDC 72854-126-16
MAXIMUM STRENGTH
MUCINEX®
FAST-MAX ®COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal DecongestantHEADACHE
SORE THROAT
CHEST CONGESTION
BODY PAIN
FEVER
COUGH
NASAL CONGESTION
SINUS CONGESTION
SINUS PRESSUREALL IN
ONE*16
LIQUID GELS
(Liquid Filled Capsules)Actual Size
FOR AGES 12 +
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-126 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color orange Score no score Shape OVAL Size 24mm Flavor Imprint Code AR01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-126-16 2 in 1 CARTON 07/26/2021 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:72854-126-08 1 in 1 CARTON 07/26/2021 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:72854-126-10 1 in 1 CARTON 07/26/2021 3 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 final part341 07/26/2021 Labeler - RB Health (US) LLC (081049410)