TRICODE GF
-
codeine phosphate,
guaifenesin and
pseudoephedrine hydrochloride liquid
Respa Pharmaceuticals, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate* 8 mg
*(Warning: May be habit-forming)
Guaifenesin 200 mg
Pseudoephedrine Hydrochloride 30 mg
Purpose
Antitussive (Cough Suppressant)
Expectorant
Nasal Decongestant
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do not use this product
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- a cough that occurs with too much phlegm (mucus)
- chronic pulmonary disease or shortness of breath, or children who are taking other drugs
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product
- May cause or aggravate constipation
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
- new symptoms occur
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of the reach of children.
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
Adults and children 12 years of age and over:
| 2 teaspoonfuls every 4 to 6 hours, not to exceed 12 teaspoonfuls in a 24 hour period
|
Children 6 to under 12 years of age:
| 1 teaspoonful every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hour period
|
Children under 6 years of age
| Consult a doctor
|
A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Other information
Store at 15°- 30°C (59°- 86°F)
Inactive ingredients
Bitter Mask, Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Questions? Comments?
Call (630) 543-3333
Rx Only
CV
Manufactured for:
RESPA
PHARMACEUTICALS, INC.
Addison, IL 60101
Product Packaging
The packaging below represents the labeling currently used:
Principal display panel and side panel for 473 mL label:
NDC 60575-414-16
__________________________________________
Tricode GF
Cough Suppressant / Expectorant
Nasal Decongestant
__________________________________________
CV
Each 5 mL (one teaspoonful) for oral administration
contains:
Codeine Phosphate*.......................................8 mg
*(Warning: May be habit-forming)
Guaifenesin................................................200 mg
Pseudoephedrine HCl....................................30 mg
Grape Flavor
Rx Only
RESPA
PHARMACEUTICALS, INC.
Addison, IL 60101
16 fl oz. (473 mL)
SEE ATTACHED PRODUCT INSERT FOR COMPLETE
DOSING INFORMATION.
Tamper evident by foil seal under cap. Do not use if
foil seal is broken or missing.
Dispense in a tight, light-resistant container as defined
in the USP/NF with a child-resistant closure.
Store at controlled room temperature, 15°- 30°C (59°- 86°F).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH
OF CHILDREN.
Manufactured for:
Respa Pharmaceuticals
Addison, IL 60101
Rx Only
Rev. 05/11
TRICODE
GF
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid |
|
|
|
|
|
Revised: 06/2011 Respa Pharmaceuticals, Inc.