Label: TRICODE GF- codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 60575-414-16 - Packager: Respa Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
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 Label Information
Updated September 9, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
-
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 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.
- 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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of the reach of children.
-
Directions
Do not exceed recommended dosage.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.
Adults and children
12 years of age
and over:
2 teaspoonfuls (10 mL)
every 4 to 6 hours,
not to exceed 8 teaspoonfuls
in a 24 hour period
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 4 to 6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period
Children under 6
years of age
Consult a doctor.
- Other information
- Inactive ingredients
- Questions? Comments?
-
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
Dye Free / Sugar Free
Alcohol Free / Gluten Free
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.
THIS BOTTLE IS NOT TO BE DISPENSED TO
THE CONSUMER.
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. 08/11
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INGREDIENTS AND APPEARANCE
TRICODE GF
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-414 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 8 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 mg in 5 mL Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength Citric Acid (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60575-414-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/20/2011 Labeler - Respa Pharmaceuticals, Inc. (883901019)