Codeine-guaifenesin Oral Solution

Codeine-guaifenesin Oral Solution
SPL v100
SPL
SPL Set ID 9812056b-736e-40c5-ae60-21dd9221397c
Route
ORAL
Published
Effective Date 2011-12-30
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, Unspecified Form Sucralose Sorbitol Sodium Benzoate

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

How Supplied

Guaifenesin USP 10-100 mg/5mL NDC: 72162-1669-2: 120 mL in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antitussive

How Supplied

Guaifenesin USP 10-100 mg/5mL

NDC: 72162-1669-2: 120 mL in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.
Section 51945-4

Guaifenesin-Codeine Solution 100-10mg/ 5ml

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,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

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.
Section 51945-4 (51945-4)

Guaifenesin-Codeine Solution 100-10mg/ 5ml

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.
How Supplied (HOW SUPPLIED)

Guaifenesin USP 10-100 mg/5mL

NDC: 72162-1669-2: 120 mL in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:53.965129 · Updated: 2026-03-14T23:02:42.365017