Label: MUCUS RELIEF CONGESTION AND COUGH MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
- NDC Code(s): 11673-337-06
- Packager: TARGET Corporation
- 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 December 15, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
-
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 irritant
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
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Warnings
Do not use
- if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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.
- for children under 12 years of age
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, emphysema
- cough that occurs with too much phlegm (mucus)
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Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL= milliliter
- shake well before using
- adult and children 12 years of age and older: 20 mL in dosing cup provided avery 4 hours
- Children under 12 years of age do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*
maximum strength
fast mucus relief severe congestion and cough
dextromethorphan HBr 20 mg (cough suppressant)
guaifenesin 400 mg (expectorant)
phenylephrine HCI 10 mg (nasal decongestant)
controls cough
relieves nasal and chest congestion
thins and loosens mucus
AGES 12 + YEARS
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Dist. by Target Corp.
Minneapolis, MN 55403
- Product Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF CONGESTION AND COUGH MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-337 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) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-337-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2016 Labeler - TARGET Corporation (006961700)
