Codeine-Guaifenesin
- Dosage form
- SOLUTION
- Labeler
- Proficient Rx LP
- Label updated
- 2024-10-01
- Retrieved
- 2026-09-07
- Active ingredients
- Codeine Phosphate · Guaifenesin
Label information
Drug Facts
유효 성분
성분·작용
| Active ingredients (in each 5 mL = 1 tsp) | Purpose |
|---|---|
|
Codeine phosphate, USP 10 mg |
Antitussive |
|
Guaifenesin, USP 100 mg |
Expectorant |
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.
-
Warnings
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
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.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
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)
[Image in the official label — see DailyMed source]
DailyMed Set ID: 20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d · Version 2
NDC: 71205-624