Label: BIOCOF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 45737-249-16
- Packager: Advanced Generic Corporation
- 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 December 23, 2020
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ACTIVE INGREDIENT
Active Ingredients (in each 5 mL tps.) Purpose
Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant
Guaifenesin.... 400 mg........................................................Expectorant
Phenylephrine HCL.....10 mg...............................................Nasal Decogestant
- PURPOSE
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WARNINGS
Warnings:
Ask a doctor before use if you have:
- Heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to an enlarged prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargment or prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.
When using this product do not use more than directed.
Stop use and ask a doctor if: you get nervous, dizzy, or sleepless; symptoms do not get better within 7 days, or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by a fever, rash or persistent headache. These could be signs of serious condition.
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DO NOT USE
Do not use:
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of depression, psychiatric, or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOCOF
dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-249 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM CITRATE (UNII: 1Q73Q2JULR) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-249-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2012 Labeler - Advanced Generic Corporation (831762971)