Label: MUCUS RELIEF SEVERE CONGESTION AND COUGH- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 76162-040-45
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
-
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
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- diabetes
- thyroid disease
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
+TopCare®
healthNDC 76162-040-45
COMPARE TO MUCINEX® FAST-MAX® SEVERE
CONGESTION & COUGH ACTIVE INGREDIENTS*MAXIMUM STRENGTH
Mucus Relief
Severe Congestion
& Cough
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
GUAIFENESIN • EXPECTORANT
PHENYLEPHRINE HCl • NASAL DECONGESTANTMULTI-SYMPTOM RELIEF:
• Controls Cough
• Relieves Nasal &
Chest Congestion
• Thins & Loosens
MucusFOR AGES 12+
6 FL OZ (177 mL)
Mixed Berry
FlavoredTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSINGPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgDISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0223 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/4902b6*This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Mucinex® FAST-MAX® Severe Congestion & Cough.
50844 ORG042300445TopCare 44-004 ORG0423
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF SEVERE CONGESTION AND COUGH
dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-040 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color blue Score Shape Size Flavor BERRY (MIXED) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-040-45 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/10/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/10/2023 Labeler - TOPCO ASSOCIATES LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(76162-040) , pack(76162-040)