Label: BIOCOTRON-D- dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ drops
- NDC Code(s): 45737-208-16
- 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings:
Ask a doctor before use if you have:Heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant.
When using this product do not use more than directed.
- PREGNANCY OR BREAST FEEDING
-
DO NOT USE
Do not use.
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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop use and ask a doctor before use if:
- you get nervous, dizzy or sleepless; symptoms do not get better within 7 or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions: Do not take more than 3 doses in any 24-hour period.
Age
Dose
Adults and children 12 years of age and over
2 teaspoons every 4 hours
Children 6 to under 12 years of age
1 teaspoon every 4 hours
Children 2 to under 6 years of age 1/2 teaspoon every 4 hours
Children under 2 years of age Ask a doctor
- INACTIVE INGREDIENT
- QUESTIONS
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOCOTRON-D
dextromethorphan hbr, guaifenesin, phenylephrine hcl suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-208 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM BENZOATE (UNII: OJ245FE5EU) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) 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:45737-208-16 473 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)
