Label: BIOGTUSS- dextromethorphan, guaifenesin, phenylephrine liquid
- NDC Code(s): 45737-205-16
- 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
- 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)