BRONCOCHEM EXPECTORANT II- acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl syrup

BRONCOCHEM by

Drug Labeling and Warnings

BRONCOCHEM by is a Otc medication manufactured, distributed, or labeled by LABORATORIO MAGNACHEM INTERNATIONAL SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus).  Likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor.  A persistent cough may be a sing of a serious condition. Stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache.  As with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. Unless directed by a doctor, do not take this product if you are presently taking another product containing Pseudoephedrine HCl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect.  Avoid alcoholic beverages while taking this product.  Use caution when driving a motor vehicle or operating machinery.

Active Ingredients

Acetaminophen

Chlorpheniramine Maleate

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Purpose

Analgesic

Antihistaminic

Antotussive

Expectorant

Decongestant

Keep Out Of the Reach Of children

In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately

Indications & Use

Bronchial congestion

Irritation of the respiratory passages

Nasal congestion

Helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive

Antitussive

Temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Dosage and Administration

Do not exceed 4 doses in a 24 hour period

Adults and chuildren 12 years and over: (10mL or cc) using metered dosage spoon every 6 hours.

Children 6 years up to 12 years: (5mL or cc) using metered dosage spoon every 6 hours

Drug Interaction Precautions

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI). (certain drugs for depression, psychiatric or emotional conditions, or Parkinson`s disease), or 2 weeks after stopping the MAOI drug.  If you are uncertain whether your presciption drug contains an MAOI, consult a health professional before taking this product

Iactive Ingredient

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

Package Label Principal Display Panel

Iactive Ingredient

Aloe Vera, Ammonium Glycyrrhizinate, Citric acid, Disodium EDTA, Glacial Acetic Acid, Natural Raspberry flavor, Propylene Glycol USP, Purified Water, FD&C Red No.40, Sodium Benzoate, Sodium Saccharin USP, Sorbitol 70%.

INGREDIENTS AND APPEARANCE

BRONCOCHEM  EXPECTORANT II
acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg  in 10 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	13.33 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	40 mg  in 10 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	20 mg  in 10 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	12 mg  in 10 mL
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)	6 mg  in 10 mL
DISODIUM HEDTA (UNII: KME849MC7A)	5 mg  in 10 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	2 mg  in 10 mL
SORBITOL (UNII: 506T60A25R)	2.3 mL  in 10 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	2 mL  in 10 mL
ACETIC ACID (UNII: Q40Q9N063P)	0.016 mL  in 10 mL
RASPBERRY (UNII: 4N14V5R27W)	0.006 mL  in 10 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.29 mg  in 10 mL
WATER (UNII: 059QF0KO0R)	10 mL  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-116-87	1 in 1 BOX	12/30/2016
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 not final	part343	12/30/2016

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(65131-116)