Topcare Tab Tussin
FDA Label NDC 36800-442

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 Tab Tussin (NDC 36800-442). 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 active ingredient - (per tablet), ask doctor before use, stop use and ask doctor if, do not use, keep out of reach of children,, pregnant or breastfeeding, inactive ingredients, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient - (Per Tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant

Ask Doctor Before Use

If you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

cough is accompanied by excessive phlegm (mucous)

Stop Use And Ask Doctor If

Symptoms are accompanied by fever, rash or persistent headache

cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition

Do Not Use

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

Keep Out Of Reach Of Children,

In case of overdose, get medical help or contact a Poison Center immediately

Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Inactive Ingredients

magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.

Directions


• Adults and children 12 years of age and over:    
take 1 tablet every 4 hours as needed    
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make coughs more productive

Purpose

Cough Suppressant

Expectorant

Warning

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

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