Label: TOPCARE MUCUS D- guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended release
- NDC Code(s): 76162-801-89
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 30, 2023
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- Active ingredients (in each extended-release bi-layer tablet)
- Purposes
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Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves nasal congestion due to:
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- common cold
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- hay fever
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- upper respiratory allergies
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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- temporarily relieves sinus congestion and pressure
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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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
TopCare® health
COMPARE TO MUCINEX® D ACTIVE INGREDIENTS
Mucus-D
GUAIFENESIN 600 mg
PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
EXTENDED-RELEASE BI-LAYER TABLETS
EXPECTORANT/NASAL DECONGESTANT
12 HOUR
• Clears Nasal/Sinus Congestion
• Thins And Loosens Mucus
• Immediate and Extended Release
18 EXTENDED-RELEASE BI-LAYER TABLETS
actual size
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INGREDIENTS AND APPEARANCE
TOPCARE MUCUS D
guaifenesin and pseudoephedrine hydrochloride tablet, multilayer, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-801 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color ORANGE Score no score Shape OVAL Size 17mm Flavor Imprint Code L6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-801-89 18 in 1 CARTON 08/16/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214407 08/16/2023 Labeler - Topco Associates LLC (006935977)