Label: CODAR- codeine phosphate, pseudoephedrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60575-515-16 - Packager: Respa Pharmaceuticals
- 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 July 26, 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
- Warnings
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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.
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Ask a doctor before use if you have
- 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 mellitus
- difficulty in urination due to an enlarged prostate gland
- 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 reach of children.
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Directions
Do not exceed recommended dosage.
Adults and Children
12 years of age and
over:
2 teaspoonfuls (10 mL)
every 4-6 hours, not to
exceed 8 teaspoonfuls
in a 24 hour period.
Children 6 to under
12 years of age:
1 teaspoonful (5 mL)
every 4-6 hours, not to
exceed 4 teaspoonfuls
in a 24 hour period.
Children under 6
years of age:
Not recommended
for use.
- Other information
- Inactive ingredients
- Questions? Comments?
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Product Packaging
The packaging below represents the labeling currently used:
Principal display panel and side pane for 473 mL label:
NDC 60575-515-16
_____________________________________
Codar® D
Cough Suppressant / Nasal Decongestant
_____________________________________
CV
Each 5 mL (one teaspoonful) for oral
administration contains:
Codeine Phosphate*..............................8 mg
Pseudoephedrine HCl...........................30 mg
Berry 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. 06/11
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INGREDIENTS AND APPEARANCE
CODAR D
codeine phosphate, pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-515 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 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 Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60575-515-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/13/2011 Labeler - Respa Pharmaceuticals (883901019)