Codeine-guaifenesin Oral Solution

Codeine-guaifenesin Oral Solution
SPL v3
SPL
SPL Set ID 9e691264-d48a-6b48-e053-2995a90a9352
Route
ORAL
Published
Effective Date 2020-02-12
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 Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-01
Description

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

Purpose

Antitussive

Medication Information

Purpose

Antitussive

Description

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

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.
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.
Active Ingredient

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg

Other Information

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

Inactive Ingredients

Cherry Flavor, Citric Acid, Glycerin, Propylene glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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.
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.
Active Ingredient (Active ingredient)

(in each teaspoonful (5 mL))

Codeine Phosphate USP 10 mg

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, Glycerin, Propylene glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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.
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: 2026-02-15T12:03:12.212144 · Updated: 2026-03-14T23:03:09.210552