Label: CODAR AR- chlorpheniramine maleate, codeine phosphate liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 60575-212-16 - 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 June 20, 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 runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other upper respiratory allergies (allergic rhinitis). Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants and helps you cough less.
- Warnings
-
Do not take this product, unless directed by a doctor before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- a chronic pulmonary disease, shortness of breath, or children who are taking other drugs
- a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma
- difficulty in urination due to enlargement of the prostate gland.
- Ask a doctor before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep this and other drugs 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 effects for your child.
Adults and Children
12 years of age and
over:
2 teaspoonfuls (10 mL)
every 4-6 hours, not to
exceed 12 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 6 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 60575-212-16
_____________________________________________
Codar AR
Antihistamine / Cough Suppressant
_____________________________________________
Each 5 mL (one teaspoonful) for oral
administration contains:
Chloropheniramine Maleate................................2 mg
Codeine Phosphate*..........................................8 mg
*(Warning: May be habit-forming)
CV
Apple Flavor
Rx Only
RESPA
PHARMACEUTICALS, INC.
Addision, 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
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INGREDIENTS AND APPEARANCE
CODAR AR
chlorpheniramine maleate, codeine phosphate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-212 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 Inactive Ingredients Ingredient Name Strength Citric Acid (UNII: 2968PHW8QP) 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 APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60575-212-16 473 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)