Label: MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 41520-037-06
- Packager: Care One (American Sales Company)
- 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.
Updated October 30, 2019
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- Active ingredients (in each 20 mL)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
Do not use
- for children under 12 years of age
- 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
- heart disease
- 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
- symptoms do not get better within 7 days or occur with fever
- cough comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition.
- do not take more than 6 doses in a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- shake well before using
- 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
Principal Display Panel
Compare to the Active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*
SEVERE CONGESTION & COUGH
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl
Clears Nasal & Chest Congestion,
Thins & Loosen Mucus
For Ages 12+
FL OZ (mL)
Questions or comments? Call 1-877-753-3935 Mondy-Friday 9AM-5PM EST
FOODHOLD U.S.A LLC
LANDOVER , MD 20785
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.
- Package Label
INGREDIENTS AND APPEARANCE
MUCUS RELIEF MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-037 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-037-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/31/2014 Labeler - Care One (American Sales Company) (809183973)