Label: GUAIFENESIN D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release
- NDC Code(s): 0536-1333-21, 0536-1333-36
- Packager: RUGBY LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 16, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
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- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton
Rugby®
NDC 0536-1333-36
Compare to the active
ingredients in Mucinex® D†Guaifenesin and
Pseudoephedrine HCl
Extended-Release Tablets
Guaifenesin 600 mg
Pseudoephedrine HCl 60 mg600 mg/60 mg
Expectorant and Nasal Decongestant
12 Hour
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- Clears Nasal/Sinus Congestion
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- Thins and Loosens Mucus
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- Immediate and Extended Release
Actual Size
36 Extended-Release Tablets
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INGREDIENTS AND APPEARANCE
GUAIFENESIN D
guaifenesin and pseudoephedrine hydrochloride tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1333 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code 058 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1333-36 2 in 1 CARTON 04/04/2022 1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0536-1333-21 1 in 1 CARTON 04/04/2022 2 18 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 ANDA212542 04/04/2022 Labeler - RUGBY LABORATORIES, INC. (079246066) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 MANUFACTURE(0536-1333)