Otc - Active Ingredient
Active Ingredients (In Each Tablet)
Guaifenesein 400 mg
Phenylephrine HCl 10 mg
Dextromethorphan HBr. 20 mg
Tusicof
FDA Label NDC 52083-289
Full FDA labeling including 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 52083-289). 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 otc - active ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant, nasal decongestant, antitussive (anti cough)
Indications & Usage
Uses: temporarily relieves these symptoms occurring with a cold
nasal decongestion: cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Dosage & Administration
Directions:
Adults and children 12 years of age and older
• Take 1 tablet every 4 hours as needed, do not exceed 6
tablets in 24 hours, or as directed by a doctor.
• Children under 12 years, consult a doctor
• Warnings:
Warnings
Warnings:
• when using this product do not exceed recommended dose.
• 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 MAOI drug. If you do not know if your prescription
drug contains an MAOI, consult a doctor or pharmacist before
taking this product
Stop use and ask a doctor if:
• symptoms do not improve
• new symptoms occur
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by
fever
• cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional
before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. In case of overdose,
get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Inactive Ingredient
Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Starch Glycolate, Stearic Acid
Package Label.Principal Display Panel
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