NDC | 45737-246-16 |
Set ID | c2f176e9-b647-43a6-96cd-bad48dd776e9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Advanced Generic Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
-
PURPOSE
Uses
- Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
- Cough due to minor throat and bronchial irritation
- Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
- Nasal congestion
- Reduces swelling of nasal passages.
-
WARNINGS
Warnings
- Do not exceed recommended dosage
- A
persistent cough may be a sign of a serious condition. If cough
persists for more than a week, tends to reoccur or is accompanied by a
fever, rash or persistent headache, consult a doctor
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
- If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
- Do not exceed recommended dosage
-
DO NOT USE
Do not Use
- For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
- If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
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 your doctor or pharmacist before taking this product. - KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- QUESTIONS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOBRON DX
dextromethorphan, guaifenesin, phenylephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-246 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 200 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN CALCIUM (UNII: 5101OP7P2I) 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:45737-246-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2009 Labeler - Advanced Generic Corporation (831762971)