BRONCOCHEM MAXIMUM COUGH NIGHT- dextromethorphan hbr-pyrilamine maleate syrup 
LABORATORIO MAGNACHEM INTERNATIONAL SRL

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Broncochem Maximum Cough Night 

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

Antitussive

Antihistamine

OTC - Active Ingredient Section

Dextromethorphan HBr

Mepyramine maleate

Uses

Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.

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.

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

Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.

Keep Out of the Reach of Children 

In case of accidental overdose, seek professional help or go to poison control center immediately.

Dosage and Administration

Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: (5 or 10 mL) 3 times a day.

Children between 6 to 12 years old: (2.5 mL) 3 times a day.

Inactive Ingredient

Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Broncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpgBroncochem Maximum Cough_Bottle Label_10232023_ProductionFile-01.jpg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

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BRONCOCHEM  MAXIMUM COUGH NIGHT
dextromethorphan hbr-pyrilamine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE6 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-035-801 in 1 BOX02/09/2024
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02/09/2024
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-035)

Revised: 4/2024
Document Id: 5c804db7-1a93-4b7c-9c07-11cd3e80e246
Set id: 1a3ed214-e09b-4266-b68b-39e7c3127d26
Version: 3
Effective Time: 20240422
 
LABORATORIO MAGNACHEM INTERNATIONAL SRL