Tusicof Syrup
FDA Label NDC 52083-239
11 label sections · Submitted to the FDA by Kramer Novis · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Tusicof (NDC 52083-239). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 5 ml, 1 teaspoon), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5 Ml, 1 Teaspoon)
Dextromethorphan HBr, 20mg
Guaifenesin, 400 mg
Phenylephrine HCl, 10 mg
Purposes
Cough suppressant
Expectorant
Nasal decongestant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation
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 • diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
When using this product, do not use more than directed.
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not take more than 6 doses in any 24-hour period. • mL= milliliter
| age | dose |
| Adults and children 12 years of age and over | 1 teaspoon (5 mL) every 4 hours |
| Children under 12 years of age | do not use |
Other Information
• Tamper evident feature: Do not use if printed security seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat or humidity.
Inactive Ingredients
artificial flavor, citric acid, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Questions Or Comments?
1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST
Packaging
Tusicof (52083239 2)
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