TRICODE GF- codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

Tricode by

Drug Labeling and Warnings

Tricode by is a Otc medication manufactured, distributed, or labeled by Respa Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
• nervousness, dizziness, or sleeplessness occur
• 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, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

• Adults and children12 years of ageand over: 2 teaspoonfuls (10 mL); every 4 to 6 hours,; not to exceed 8 teaspoonfuls ; in a 24 hour period
• Children 6 to under12 years of age: 1 teaspoonful (5 mL); every 4 to 6 hours, not to ; exceed 4 teaspoonfuls; in a 24 hour period
• Children under 6years 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 SuppressantŠ·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

INGREDIENTS AND APPEARANCE

TRICODE  GF
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

Product 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)