Label: BRONKIDS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49963-532-01, 49963-532-04 - Packager: Portal Pharmaceutical
- 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 November 21, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Uses
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Warnings
Do not exceed recommended dosage.
Do not use this product
- if you are taking a prescription monamine 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- if you are taking a prescription monamine 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Directions
- Other information
- Inactive ingredients
- Questions? Comments?
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Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 118 mL label:
NDC 49963-532-04
Antihistamine/Antitussive/Nasal Decongestant
Bronkids
Liquid
Strawberry Flavor
Each 5 mL (one teaspoonful) for
oral administration contains:
Chlorpheniramine Maleate.........................4 mg
Dextromethorphan Hydrobromide.............10 mg
Phenylephrine Hydrochloride...................10 mg
Gluten Free
4 fl oz
(118 mL)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Manufactured for:
PORTAL
Pharmaceutical
Mayaguez, PR 00680
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INGREDIENTS AND APPEARANCE
BRONKIDS
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49963-532 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 4 mg in 5 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength Citric Acid (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium Citrate (UNII: 1Q73Q2JULR) Saccharin Sodium (UNII: SB8ZUX40TY) Sorbitol (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49963-532-04 118 mL in 1 BOTTLE 2 NDC:49963-532-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/10/2011 Labeler - Portal Pharmaceutical (831005199)