Label: BRONCOCHEM MAXIMUM COUGH NIGHT- dextromethorphan hbr-pyrilamine maleate syrup
- NDC Code(s): 65131-035-80
- Packager: LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 22, 2024
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Warnings
The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately. Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping.
- OTC-PURPOSE SECTION
- OTC - Active Ingredient Section
- Uses
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Do Not Use
Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.
If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them). If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.
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Ask a doctor/pharmacist
Ask a doctor before use if yoy have
Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
- Stop use and ask a doctor if
- Keep Out of the Reach of Children
- Dosage and Administration
- Inactive Ingredient
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOCHEM MAXIMUM COUGH NIGHT
dextromethorphan hbr-pyrilamine maleate syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65131-035 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 PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 6 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUGARCANE (UNII: 81H2R5AOH3) 2.65 mg in 5 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 10 mg in 5 mL FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.25 mg in 5 mL ORANGE OIL (UNII: AKN3KSD11B) 0.833 mg in 5 mL METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) 5 mg in 5 mL PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) 1.5 mg in 5 mL ALCOHOL 95% (UNII: 7528N5H79B) 0.25 mL in 5 mL SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) 0.083 mL in 5 mL water (UNII: 059QF0KO0R) 5 mL in 5 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65131-035-80 1 in 1 BOX 02/09/2024 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 Drug M 02/09/2024 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(65131-035)
