Codeine-guaifenesin
e9705358-3522-46b3-a860-afb9141968b4
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
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 17856-0273-01
CODEINE-GUAIFENESIN 10-100MG - 5 ML CUP 72 ct UD
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)
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.
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
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 17856-0273-01
CODEINE-GUAIFENESIN 10-100MG - 5 ML CUP 72 ct UD
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)
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:03.961491 · Updated: 2026-03-14T23:02:55.861635