BRONCOCHEM KIDS ALLERGY CONTROL- chlorpheniramine maleate-dextromethrophan hbr syrup

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

इसे खरीदें

सक्रिय संघटक:
Dextromethorphan HBr.......10.00mg, Chlorpheniramine maleate...2.00mg
थमां उपलब्ध:
LABORATORIO MAGANCEHM INTERNATIONAL SRL
प्रशासन का मार्ग:
ORAL
प्रिस्क्रिप्शन प्रकार:
OTC DRUG
चिकित्सीय संकेत:
Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive. Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis Cough with lots of phlegm Chornic cough, asthma or emphysema Respiratory problems Chornic bronchitis If your child is allergyc to another component of this formula Symptoms last more than 5 days If your child feels dizziness, nervous or cannot sleep If the cough present fever and headache, this could be signs of a serious conditions If new symptoms occur Dextromethorphan HBr------Antitussive Chlorpheniramine maleate--Antihistamine
प्राधिकरण का दर्जा:
OTC monograph final
प्राधिकरण संख्या:
65131-418-09

BRONCOCHEM KIDS ALLERGY CONTROL- chlorpheniramine maleate-dextromethrophan

hbr syrup

LABORATORIO MAGANCEHM 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.

----------

BRONCOCHEM KIDS ALLERGY CONTROL

Warnings

Do not use

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weks after stopping

the MAOI drug (certain drugs for depression, psuchiatric or emotional conditions may contain MAOI),

if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking

this product

active ingredients

Dextromethorphan HBr.......10.00mg

Chlorpheniramine maleate...2.00mg

Us es

Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial

secretions to make coughs more productive.

Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy

throat, Allergy rhinitis

Ask a doctor before use if your kid have

Cough with lots of phlegm

Chornic cough, asthma or emphysema

Respiratory problems

Chornic bronchitis

If your child is allergyc to another component of this formula

Stop use and ask a doctor if

Symptoms last more than 5 days

If your child feels dizziness, nervous or cannot sleep

If the cough present fever and headache, this could be signs of a serious conditions

If new symptoms occur

Keep out of the reach of children

Keep out of the reach of children

Overdose warning

in case of accidental overdose, seek professional assistance or contact a poison control center

immediately

Directions

Take only as directed, for your convenience a dosage spoon is provided

Do not exceed 4 doses in a 24-hour period

Children from 6 to 12 years-----10mL or cc every 6 hours

Children fron 2 to 6 years-------5mL or cc every 6 hours

Children under 2 years, ask your doctor

Other information

Store at 66-77*F (20-25*C), do not use if security cap is altered or broken

Inactive Ingredients

Propylene glycol, Gliceryn, Sorbitol 70%, Sucralose, Povidone, Sodium Chloride, Aloe vera,

Methylparaben USP, Propylparaben USP, Ascorbic acid, Color Yellow #5, Dosodium Hedta, Orange

flavor, Sodium hydroxide, Purified water

Quies tions ?

1-561-338-5221 or visit us at www.broncochem.com

Purpos e

Dextromethorphan HBr------Antitussive

Chlorpheniramine maleate--Antihistamine

Package Label Principal Display Panel

Package Label Principal display Panel

BRONCOCHEM KIDS ALLERGY CONTROL

chlorpheniramine maleate-dextromethrophan hbr syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 5131-418

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

2 mg

in 10 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

1.5 mL in 10 mL

GLYCERIN (UNII: PDC6 A3C0 OX)

2 mL in 10 mL

SO RBITO L (UNII: 50 6 T6 0 A25R)

2 mL in 10 mL

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

8 .33 mg in 10 mL

PO VIDO NE K9 0 (UNII: RDH8 6 HJV5Z)

10 0 mg in 10 mL

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

6 .25 mg in 10 mL

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

4 mg in 10 mL

METHYLPARABEN (UNII: A2I8 C7HI9 T)

10 mg in 10 mL

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

1.5 mg in 10 mL

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

6 6 mg in 10 mL

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

0 .5 mg in 10 mL

DISO DIUM HEDTA (UNII: KME8 49 MC7A)

0 .9 mg in 10 mL

LABORATORIO MAGANCEHM INTERNATIONAL SRL

O RANGE (UNII: 5EVU0 4N5QU)

0 .0 0 16 mg in 10 mL

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

13.33 mg in 10 mL

WATER (UNII: 0 59 QF0 KO0 R)

10 mL in 10 mL

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

ORANGE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 5131-418 -

1 in 1 BOX

0 5/0 1/20 17

1

120 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 1/20 17

Labeler -

LABORAT ORIO MAGANCEHM INT ERNAT IONAL SRL (871446100)

Registrant -

LABORAT ORIO MAGNACHEM INT ERNAT IONAL SRL (871446100)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LABORATORIO MAGNACHEM INTERNATIONAL SRL

8 71446 10 0

ma nufa c ture (6 5131-418 )

Revised: 4/2017

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