codeine-guaifenesin oral solution

codeine-guaifenesin oral solution
SPL v15
SPL
SPL Set ID fe126254-6ee6-48c3-965c-96e4276a5314
Route
oral
Published
Effective Date 2020-07-10
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 citrate sucralose sorbitol sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-04-01
Purpose

Antitussive

Description

(in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg

Medication Information

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.
Purpose

Antitussive

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).

Inactive Ingredients

Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

Description

(in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg

Principal Display Panel

NDC 58657-500-16







Codeine-Guaifenesin Oral Solution







10-100 mg/5 mL







Antitussive







Expectorant







16 fl. oz. (473 mL)

Active Ingredient

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg

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.
If Pregnant Or Breast Feeding

ask a health professional before use.

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
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 makes cough more productive.
Purpose

Antitussive

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).

Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

Principal Display Panel

NDC 58657-500-16







Codeine-Guaifenesin Oral Solution







10-100 mg/5 mL







Antitussive







Expectorant







16 fl. oz. (473 mL)

Active Ingredient (Active ingredient)

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg

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.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

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
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:31.533634 · Updated: 2026-03-14T23:13:21.652895