Label: BRONCOCHEM ALLERGY CONTROL- cholpheniramine maleate-phenylephrine hcl syrup
- NDC Code(s): 65131-098-47
- Packager: LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Category: HUMAN OTC DRUG LABEL
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 March 14, 2017
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Warnings
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 oharmacist before taking this product.
- Uses
- PURPOSE
- Active ingredients (in 10 mL or cc)
- Ask a doctor or Pharmacist if you
- When Using this Product
- Stop Use and Ask a Doctor If
- Keep Out of the Reach of children
- Overdose warning
- Directions
- Other Information
- Inactive Ingredients
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PAKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOCHEM ALLERGY CONTROL
cholpheniramine maleate-phenylephrine hcl syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65131-098 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 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg in 10 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.2 mL in 10 mL GLYCERIN (UNII: PDC6A3C0OX) 2 mL in 10 mL SORBITOL (UNII: 506T60A25R) 2 mL in 10 mL SUCRALOSE (UNII: 96K6UQ3ZD4) 7.5 mg in 10 mL POVIDONE K90 (UNII: RDH86HJV5Z) 100 mg in 10 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.25 mg in 10 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 4 mg in 10 mL METHYLPARABEN (UNII: A2I8C7HI9T) 10 mg in 10 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 1.5 mg in 10 mL PROPYL GALLATE (UNII: 8D4SNN7V92) 1 mg in 10 mL CITRIC ACID ACETATE (UNII: DSO12WL7AU) 20 mg in 10 mL TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 40 mg in 10 mL EDETATE SODIUM (UNII: MP1J8420LU) 0.9 mg in 10 mL GRAPEFRUIT (UNII: O82C39RR8C) 0.0048 mL in 10 mL WATER (UNII: 059QF0KO0R) 10 mL in 10 mL Product Characteristics Color Score Shape Size Flavor grape Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65131-098-47 1 in 1 BOX 04/01/2017 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 04/01/2017 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(65131-098)