NDC | 45737-227-16 |
Set ID | d6b2d191-e2fb-4da4-92e0-35b81e07e673 |
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 cough due to minor throat and bronchial irritation as may occur with common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus
- temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation.
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold
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WARNINGS
Warnings
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 your doctor or pharmacist before taking this product.
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DO NOT USE
Do not Use
- In a child under 2 years of age.
Ask a doctor before use if child has- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if your child- gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days 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 serous condition.
- In a child under 2 years of age.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions Do not exceed 6 doses in 24 hours.
adults and children 12 years of age and over take 4 teaspoonful (20 mL) every 4 hours
children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hourschildren 2 to under 6 years of age take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age ask doctor
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOTPRES PEDIATRIC
dextromethorphan, guaifenesin, phenylephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-227 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 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 75 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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) Glycerin (UNII: PDC6A3C0OX) Hydroxymethyl Cellulose (UNII: 273FM27VK1) Product Characteristics Color Score Shape Size Flavor ORANGE (Orange Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-227-16 473 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)