Label: MUCINEX FAST-MAX COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
- NDC Code(s): 63824-015-66, 63824-015-69
- 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 January 14, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- stuffy nose
- sinus congestion and pressure
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (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:
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses 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 sever skin reactions. Symptoms may include:
- skin reddening
- blister
- 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.
- if you are now taking a prescription 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 prescription 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
- persistent 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.
- Overdose warning
-
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
MAXIMUM STRENGTH*
NDC 63824-015-66Mucinex®
FAST-MAX®COLD, FLU
& SORE THROATAcetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant • Phenylephrine HCl – Nasal Decongestant- ✓
- Controls Cough, Thins & Loosens Mucus
- ✓
- Nasal & Chest Congestion
- ✓
- Sinus Pressure & Congestion
- ✓
- Body Pain, Headache, Fever & Sore Throat
6 FL OZ (180 mL)
FOR AGES 12+071817
3051674 -
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen 650 mg in 20 mL dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide 20 mg in 20 mL guaifenesin (UNII: 495W7451VQ) (guaifenesin - UNII:495W7451VQ) guaifenesin 400 mg in 20 mL phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) FD&C Blue NO. 1 (UNII: H3R47K3TBD) FD&C Red NO. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) propyl gallate (UNII: 8D4SNN7V92) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) trisodium citrate dihydrate (UNII: B22547B95K) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-015-66 180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 02/07/2012 2 NDC:63824-015-69 266 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 02/07/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/07/2012 Labeler - RB Health (US) LLC (081049410)