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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Available from:
LABORATORIO MAGNACHEM INTERNATIONAL SRL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Analgesic Antihistaminic Antotussive Expectorant Decongestant 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
Authorization status:
OTC monograph not final
Authorization number:
65131-116-87

BRONCOCHEM EXPECTORANT II- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride syrup

LABORATORIO MAGNACHEM INTERNATIONAL SRL

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.

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BRONCOCHEM EXPECTORANT II

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%.

BRONCOCHEM EXPECTORANT II

LABORATORIO MAGNACHEM INTERNATIONAL SRL

acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl syrup

Product Information

Product Type

HUMAN OTC DRUG LABEL

Item Code (Source)

NDC:65131-116

Route of Administration

ORAL

DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

ACETAMINOPHEN

(ACETAMINOPHEN)

ACETAMINOPHEN

250 mg in 10 mL

CHLORPHENIRAMINE MALEATE

(CHLORPHENIRAMINE)

CHLORPHENIRAMINE MALEATE

4 mg in 10 mL

DEXTROMETHORPHAN HYDROBROMIDE

(DEXTROMETHORPHAN)

DEXTROMETHORPHAN HYDROBROMIDE

13.33 mg in 10 mL

GUAIFENESIN

(GUAIFENESIN)

GUAIFENESIN

200 mg in 10 mL

PHENYLEPHRINE HYDROCHLORIDE

(PHENYLEPHRINE)

PHENYLEPHRINE

5 mg in 10 mL

Inactive Ingredients

Ingredient Name

Strength

SACCHARIN SODIUM

40 mg in 10 mL

SODIUM BENZOATE

20 mg in 10 mL

SODIUM CHLORIDE

12 mg in 10 mL

AMMONIUM GLYCYRRHIZATE

6 mg in 10 mL

DISODIUM HEDTA

5 mg in 10 mL

CITRIC ACID MONOHYDRATE

2 mg in 10 mL

SORBITOL

2.3 mL in 10 mL

PROPYLENE GLYCOL

2 mL in 10 mL

ACETIC ACID

0.016 mL in 10 mL

RASPBERRY

0.006 mL in 10 mL

FD&C RED NO. 40

0.29 mg in 10 mL

WATER

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; Combination Product Type = C112160

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)

Revised: 12/2016

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