Label: MUCINEX FAST-MAX COLD, FLU AND SORE THROAT MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 72854-127-16
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
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 July 16, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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 (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.
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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
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PRINCIPAL DISPLAY PANEL - 16 Capsule Blister Pack Carton
Fast Dissolving Liquid Gels!
NDC 72854-127-16
MAXIMUM STRENGTH
Mucinex®
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
✓Relieves Nasal & Chest Congestion
✓Relieves Headache
✓Reduces Fever16
LIQUID GELS
(Liquid Filled Capsules)Actual Size
DAY TIME
FOR AGES 12+ -
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX COLD, FLU AND SORE THROAT MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-127 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:72854-127-16 2 in 1 CARTON 07/26/2021 1 8 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)