Active Ingredient
(in each teaspoonful (5 mL))
Codeine Phosphate USP 10 mg
(in each teaspoonful (5 mL))
Guaifenesin USP 100 mg
Codeine-guaifenesin Solution
FDA Label NDC 72162-1669
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Codeine-guaifenesin (NDC 72162-1669). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask your doctor before use if, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antitussive
Expectorant
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.
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.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of 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).
Inactive Ingredients
Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.
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
Package Label.Principal Display Panel
Guaifenesin-Codeine Solution 100-10mg/ 5ml
Label (Lbl721621669)
* Please review the disclaimer below.
