Codeine Guaifenesin
FDA Label NDC 69315-248

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leading Pharma, Llc for the product Codeine Guaifenesin (NDC 69315-248). 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, uses, warnings, ask your doctor before use if, when using this product, stop use and ask a doctor if, directions, information for patients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients                                                              Purpose

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg ................... Antitussive

Guaifenesin USP 100 mg ........................... Expectorant

Uses

  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • your cough to help you sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive

Warnings

Ask Your Doctor Before Use If

  • you have a persistent cough, this may be a sign of a serious condition
  • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • you have a cough that is accompanied by excessive phlegm (mucus)
  • you have chronic pulmonary disease or shortness of breath
  • giving to a child who is taking other drugs

When Using This Product

  • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be  used to give an accurate dose of this product to children under 6 years of age.
  • may cause or aggravate constipation

Stop Use And Ask A Doctor If

  • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

Directions

  • do not exceed 6 doses in 24 hours.
  • Adults and children 12 years of age and over:

    2 tsp (10 mL) every 4 hours, or as directed by a doctor.

    Children 6 to under 12 years of age:

    1 tsp (5 mL) every 4 hours, or as directed by a doctor.

    Children under 6 years of age:

    Consult a doctor.

Information For Patients

Other Information

Store at controlled room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

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