Label: MUCUS RELIEF CHILDRENS- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 76162-057-88
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 7, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 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
- nasal congestion due to a cold
- the intensity of coughing
- stuffy nose
- the impulse to cough to help the child get to sleep
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Warnings
Do not use
in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
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Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- dose as follows or as directed by a doctor
Age Dose children 6 to under 12 years 10 mL every 4 hours children 4 to under 6 years 5 mL every 4 hours children under 4 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
TopCare®
health
NDC 76162-057-88COMPARE TO MUCINEX®
CHILDREN’S MULTI-SYMPTOM COLD
ACTIVE INGREDIENTS*children's
Multi-Symptom
Cold
Mucus
ReliefDEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
GUAIFENESIN - EXPECTORANT
PHENYLEPHRINE HCl - NASAL DECONGESTANTORAL SOLUTION
• Controls Cough
• Relieves Chest Congestion
• Breaks Up Mucus
• Relieves
Stuffy NoseAges 4
to
11 YearsBERRY
FLAVORTAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO LNKA0923
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com*This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Mucinex® Children’s Multi-Symptom Cold.
50844 ORG022305788TopCare 44-057
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF CHILDRENS
dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-057-88 1 in 1 CARTON 03/07/2024 1 201 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/07/2024 Labeler - TOPCO ASSOCIATES LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(76162-057) , pack(76162-057)