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  5. Label Information: Only For Cough

FDA Label for Only For Cough

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. KEEP OUT OF REACH OF CHILDREN. OVERDOSE WARNING
    7. DIRECTIONS:
    8. OTHER INFORMATION:
    9. INACTIVE INGREDIENTS:
    10. QUESTIONS OR COMMENTS ?
    11. PACKAGING

Only For Cough Product Label

The following document was submitted to the FDA by the labeler of this product O4 Global Trading Usa, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient (In Each Tablet)



Guaifenesin 400 mg

Dextromethorphan HBr 20mg


Purpose



Expectorant

Cough suppressant


Uses:



• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


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.     

• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.

Stop use and consult a doctor

• if cough lasts more than 7 days, recurs or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Ask a doctor before use if you have

• persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough accompanied by too much phlegm (mucus)

When using this product

• do not exceed recommended dosage.

• do not use for more than 7 days

May cause or aggravate constipation.

If pregnant or breast-feeding,

ask a healthcare professional before use.


Keep Out Of Reach Of Children. Overdose Warning



In case of accidental 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.


Directions:



  • take with a full glass of water
  • do not take more than 6 tablets in 24 hours.
    •  adults and children 12 years of age & over1 tablet every 4 hrs
     children under 12 years of age Do not use


Other Information:



• Store at room temperature between 20-25°C (68-77°F).
• Store in a dry place
• Avoid excessive heat.


Inactive Ingredients:



colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl povidone, sodium starch glyconate, stearic acid, talc


Questions Or Comments ?



1-833-665-9444.


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