Codeine-guaifenesin

Codeine-guaifenesin
SPL v2
SPL
SPL Set ID c6a42780-9977-708f-e053-2a95a90a07e6
Route
ORAL
Published
Effective Date 2023-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-07-15
Description

Drug Facts

Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg   Antitussive
Guaifenesin, USP 100 mg Expectorant
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

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.
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

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg   Antitussive
Guaifenesin, USP 100 mg Expectorant
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 (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 (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (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 (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.
Ask Your Doctor Before Use If (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:53.536503 · Updated: 2026-03-14T23:01:12.726296