codeine-guaifenesin

codeine-guaifenesin
SPL v2
SPL
SPL Set ID 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d
Route
oral
Published
Effective Date 2024-10-01
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 drug active Since 2020-07-15
Description

Drug Facts

Medication Information

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

Description

Drug Facts

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
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
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)

Structured Label Content

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

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
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
Principal Display Panel 118 Ml Bottle Label (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.020658 · Updated: 2026-03-14T23:03:58.855522