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Codeine-Guaifenesin

Dosage form
SOLUTION
Labeler
Proficient Rx LP
Label updated
2024-10-01
Retrieved
2026-09-07
Active ingredients
Codeine Phosphate · Guaifenesin
View original label and images on DailyMed ↗
Label information

Drug Facts

유효 성분

성분·작용

Active ingredients (in each 5 mL = 1 tsp) Purpose

Codeine phosphate, USP 10 mg

  Antitussive

Guaifenesin, USP 100 mg

Expectorant

Uses
  • •temporarily relieves:
    • ocough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • oyour cough to help you sleep
    • ohelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs 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.

Label information

If pregnant or breast-feeding, ask a health professional before use.

Label information

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 71205-624-04

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)

[Image in the official label — see DailyMed source]

DailyMed Set ID: 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d · Version 2
NDC: 71205-624