NDC | 45737-205-16 |
Set ID | 28c143f4-1575-44fe-871c-8e281322994e |
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
-
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
- May cause or aggravate constipation
- 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 you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by 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.
If you have- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIOGTUSS
dextromethorphan, guaifenesin, phenylephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-205 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 15 mg in 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 300 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Citrate (UNII: 1Q73Q2JULR) Citric Acid Monohydrate (UNII: 2968PHW8QP) Aspartame (UNII: Z0H242BBR1) D&C Red No. 33 (UNII: 9DBA0SBB0L) FD&C Blue No. 1 (UNII: H3R47K3TBD) Hydroxymethyl Cellulose (UNII: 273FM27VK1) Product Characteristics Color Score Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-205-16 473 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)