Label: MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 0363-0681-06
- Packager: Walgreens
- 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 February 4, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purpose
-
Uses
- 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
- temporarily help you cough less
- nasal congestion due to a cold
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Warnings
Do not use
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
- diabetes
- 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)
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Directions
- 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 device
- mL = milliliter
- 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 or comments?
-
Principal Display Panel
Compare to the active ingredient in Maximum Strength Mucinex® Fast-Max® Clear & Cool® Severe Congestion & Cough††
Severe Congestion & Cough
DEXTROMETHORPHAN HBr 20 mg / COUGH SUPPRESSANT
GUAIFENESIN 400 mg / EXPECTORANT
PHENYLEPHRINE HCL 10 mg NASAL DECONGESTANT
MAXIMUM STRENGTH
- Thins & loosens mucus
- Relieves nasal & chest congestion
- Controls cough
- 12 years & older
MINT FLAVOR
FL OZ (mL)
††This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademarks Mucinex® Fast-Max® and Clear & Cool®
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0681 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) 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0681-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/31/2017 Labeler - Walgreens (008965063)