Label: CODITUSSIN AC- codeine phosphate and guaifenesin syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 70147-313-16 - Packager: Glendale Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- 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 May 10, 2016
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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 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
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Directions
Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.
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- 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 every 4 hours, not to exceed 12 teaspoons in 24 hours Children 6 to under 12 years of age: 1 teaspoonful every 4 hours, not to exceed 6 teaspoons in 24 hours *Children under 6 years of age: Consult a doctor - Other information
- Inactive ingredients
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 70147-616-16
Coditussin
ACExpectorant
Cough SuppressantCV
Each teaspoonful for oral
administration contains:Codeine Phosphate* 10 mg
*(Warning: May be habit-forming)Guaifenesin 200 mg
SUGAR FREE / DYE FREE
ALCOHOL FREECotton Candy Flavored Liquid
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.Distributed by:
Glendale Inc
Villa Park, IL 60181
16 fl oz. (473 mL)
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INGREDIENTS AND APPEARANCE
CODITUSSIN AC
codeine phosphate and guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70147-313 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70147-313-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/01/2016 Labeler - Glendale Inc (079987961)