Label: NASAL AND CHEST DECONGESTANT- guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended release
- NDC Code(s): 56062-614-62
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 2, 2026
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- Official Label (Printer Friendly)
- Active ingredients (in each extended-release 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)
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Directions
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- do not crush, chew, or break extended-release tablet
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- take with a full glass of water
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- this product can be administered without regard for timing of meals
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- adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
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Package/Label Principal Display Panel
Maximum Strength
Nasal & Chest Decongestant
Extended Release
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 1200 mg/120 mg EXPECTORANT/NASAL DECONGESTANT
• Clears nasal & sinus congestion
• Thins & loosens mucus
• Immediate & extended release
• Relieves nasal & chest congestion
• 12 hour
ACTUAL SIZE
24 Extended-release tablets
Compare to Maximum Strength Mucinex® D active ingredients.
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INGREDIENTS AND APPEARANCE
NASAL AND CHEST DECONGESTANT
guaifenesin, pseudoephedrine hydrochloride tablet, multilayer, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-614 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) Product Characteristics Color ORANGE Score no score Shape OVAL Size 22mm Flavor Imprint Code L12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-614-62 4 in 1 CARTON 04/02/2026 1 6 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 04/02/2026 Labeler - Publix Super Markets Inc (006922009)
