Only For
FDA Label NDC 73006-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O4 Global Trading Usa, Llc for the product Only For (NDC 73006-101). 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 ingredient (in each tablet), purpose, uses:, warnings:, keep out of reach of children. overdose warning, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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