NDC | 60575-313-16 |
Set ID | 2548c67a-dfff-4cfb-8f51-a1006cf54a2f |
Category | HUMAN OTC DRUG LABEL |
Packager | Respa Pharmaceuticals, Inc. |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Purpose
- Uses
- 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 breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a cough that lasts or is chronic such as occurs with smoking, asthma 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
- Ask a doctor or pharmacist before use if you are
- 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 periodChildren 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 periodChildren 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 60575-313-16
____________________________________________
Tricode AR®
Antihistamine·Cough Suppressant
Nasal Decongestant
____________________________________________
Each 5 mL (one teaspoonful) for oral administration
contains:
Chlorpheniramine Maleate.................................2 mg
Codeine Phosphate*.........................................8 mg
*(Warning: May be habit-forming)
Pseudoephedrine HCl......................................30 mg
Dye Free / Sugar Free
Alcohol Free / Gluten Free
Berry Vanilla 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
Addision, IL 60101
Rx Only
Rev. 08/11
-
INGREDIENTS AND APPEARANCE
TRICODE AR
chlorpheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-313 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 2 mg in 5 mL Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 8 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 BERRY, VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60575-313-16 473 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)