Label: BIOGTUSS TR- guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet
- NDC Code(s): 45737-605-10
- Packager: Advanced Generic Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 23, 2020
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies
- helps loosen phlegm (mucus)
- loosens nasal congestion
- thin bronchial secretions
- drain bronchial tubes
- cough and coughing and calms the cough control center
- make coughs more productive
- clears stuffy nose
- clear nasal passageways
- shrinks swollen membranes
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WARNINGS
Warnings
Do not exceed recommended dosage
Do not use this product if you are taking a 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.
Ask a doctor before use if you have:
- heart disease
- excessive phlegm (mucus)
- high blood pressure
- diabetes
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product do not use more than directed
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions: Do not exceed recommended doses in a 24-hour period
Adults and children 12 years of age and over 1 tablet every 4 hours. Do not exceed 4 tablets in 24 hours
Children 6 to 12 years of age 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
Children under 6 years of age Ask a doctor
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOGTUSS TR
guaifenesin, phenylephrine hcl, dextromethorphan hbr tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-605 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 28 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape OVAL Size 16mm Flavor Imprint Code BG;AGC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-605-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2014 Labeler - Advanced Generic Corporation (831762971)