Label: BRONCOCHEM MAXIMUM COUGH KIDS- dextromethorphan hbr-guaifenesin syrup
- NDC Code(s): 65131-180-98
- Packager: LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 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 April 10, 2017
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Warnings
Do not Use
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product.
- Uses
- Active Ingredients
- Ask a doctor before use if your kid have
- Stop use and ask a doctor if
- keep out of the reach od children
- Overdose Warnigs
- Directions
- Other Information
- Inactive Ingredients
- Quiestions
- Purpose
- Package Label Principal Display Panel
- Package Label Principal Display Panel
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOCHEM MAXIMUM COUGH KIDS
dextromethorphan hbr-guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65131-180 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 15 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2.25 mL in 15 mL GLYCERIN (UNII: PDC6A3C0OX) 2.25 mL in 15 mL SORBITOL (UNII: 506T60A25R) 2.25 mL in 15 mL SUCRALOSE (UNII: 96K6UQ3ZD4) 15 mg in 15 mL ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 45 mg in 15 mL DISODIUM HEDTA (UNII: KME849MC7A) 1.35 mg in 15 mL POVIDONE K90 (UNII: RDH86HJV5Z) 270 mg in 15 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) 45 mg in 15 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 9.37 mg in 15 mL FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) 0.036 mg in 15 mL VANILLA (UNII: Q74T35078H) 0.0006 mL in 15 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 30 mg in 15 mL METHYLPARABEN (UNII: A2I8C7HI9T) 15 mg in 15 mL PEPPERMINT (UNII: V95R5KMY2B) 0.001 mL in 15 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 2.25 mg in 15 mL WATER (UNII: 059QF0KO0R) 15 mL in 15 mL Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65131-180-98 1 in 1 BOX 05/01/2017 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2017 Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100) Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100) Establishment Name Address ID/FEI Business Operations LABORATORIO MAGNACHEM INTERNATIONAL SRL 871446100 manufacture(65131-180)
