Otc - Active Ingredient
Active ingredient - (per tablet)
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Topcare Chest Congestion And Sinus Congestion Relief Pe Tablet
FDA Label NDC 36800-989
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Chest Congestion And Sinus Congestion Relief Pe (NDC 36800-989). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Guaifenesin.......................Expectorant
Phenylephrine HCl..............Nasal decongestant
Uses
Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.
■ helps loosen phlegm (mucus)
■ clear nasal passageways
■ loosens nasal congestion
■ drain bronchial tubes
■ shrinks swollen membranes
■ clears stuffy nose
■ makes coughs more productive
Warnings
Do not exceed recommended dosage
Do Not Use
■ this product 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 are uncertain whether your prescription drug contains an MAOI, ask a health
professional.
Ask A Doctor Before Use If You Have
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ excessive phlegm;mucus
■ difficulty in urination due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
Stop Use And Ask A Doctor If
■ nervousness, dizziness or sleeplessness occurs
■ symptoms are accompanied by fever, rash,
persistent headache or excessive phlegm (mucus)
■ cough and congestion do not improve within 7 days
or tend to recur.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.
Directions
■ adults and children 12 years and over:
take 1 caplet every 4 hours as needed
■ children 6 to under 12 years:
take 1/2 caplet every 4 hours as needed
■ children under 6 years: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor.
Inactive Ingredients
lactose, magnesium silicate,
croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
titanium dioxide and triacetin
Package Label.Principal Display Panel
Image Of Carton (Carton)
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