Codeine-guaifenesin Solution
FDA Label NDC 69367-272

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Codeine-guaifenesin (NDC 69367-272). 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 other, otc - purpose, uses, ask your doctor before use if, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each 5 mL = 1 tsp)Purpose
Codeine phosphate, USP 10 mg  Antitussive
Guaifenesin, USP 100 mgExpectorant

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 make coughs more productive.

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.

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 right away.

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.

Other Information

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

You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

Inactive Ingredients

Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

Principal Display Panel - 118 Ml Bottle Label

NDC 69367-272-04

Codeine-Guaifenesin
Oral Solution
10-100 mg/5 mL

Antitussive/Expectorant

Sugar Free, Alcohol Free, Dye Free

Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP
10 mg
Guaifenesin, USP
100 mg

(WARNING: May be habit-forming)

4 fl. oz. (118 mL)

Westminster
Pharmaceuticals

Principal Display Panel (118 mL Bottle Label)

Principal Display Panel (118 mL Bottle Label)

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