Label: BIO-S-PRES DX- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
- NDC Code(s): 45737-230-01
- 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.
Updated December 23, 2020
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- ACTIVE INGREDIENT
DO NOT USE
- Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
- in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- Do not give this product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
- Stop use and ask a doctor:
- A persistent cough may be a sign of a serious condition;
- If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
INDICATIONS & USAGE
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-230 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 1 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 50 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:45737-230-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2013 Labeler - Advanced Generic Corporation (831762971)