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BRONCOCHEM COLD AND FLU TEA

Medically reviewed on September 28, 2017

Dosage form: granule, for solution
Ingredients: ACETAMINOPHEN 500mg in 13g, CHLORPHENIRAMINE MALEATE 4mg in 13g
Labeler: LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC Code: 65131-097

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 COLD AND FLU TEA

Warnings

Liver warning:

This product contains acetaminophen, severe liver damage may occur if you take:

  • More than 6 packets in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.
  • three (3) or more alcoholic drinks every day while using this product.

Sore Tthroat warning: 

If sore throat is severe, persists for more than 2 days, is accompainied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Active Ingredients

Acetaminophen.

Phenylephrine Hydrochloride.

Chlorpheniramine Maleate

Purpose

Pain reliever/fever reducer

Nasal decongestant

Antihistamine

Keep Out of the Reach of Children

In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms.

Indications and Usage

Temporarily relieves these symptoms due to a cold:

  • Minor aches and pains.
  • Minor sore throat pain.
  • Headache.
  • Nasal and sinus congestion.
  • Runny nose.
  • Sneezing
  • Itchy nose or throat.
  • Itchy, watery eyes due to hay fever.
  • Cough due to minor throat and bronchial irritation.
  • Temporarily reduces fever.

Dosage and Administration

Do not use more than directed.

Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor.

Adults and children 12 years of age and over-One packet

Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat.

Inactive Ingredients

Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL PRINCIPAL DISPLAY PANNEL

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

BRONCOCHEM  COLD AND FLU TEA
acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-097
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 13 g
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg  in 13 g
Inactive Ingredients
Ingredient NameStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg  in 13 g
ASCORBIC ACID66 mg  in 13 g
SUCROSE9483 mg  in 13 g
CITRIC ACID MONOHYDRATE1500 mg  in 13 g
HONEY100 mg  in 13 g
MALTODEXTRIN1000 mg  in 13 g
TRICALCIUM PHOSPHATE166.6 mg  in 13 g
SUCRALOSE28.43 mg  in 13 g
SILICON DIOXIDE40 mg  in 13 g
PROPYL GALLATE0.433 mg  in 13 g
ALCOHOL0.001 mL  in 13 g
Product Characteristics
Coloryellow (FD&C YELLOW NO.5) Score    
ShapeSize
FlavorLIME (LIME (CITRUS)) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65131-097-536 PACKAGE in 1 BOX
1NDC:65131-097-5213 g in 1 PACKAGE
2NDC:65131-097-1225 PACKAGE in 1 BOX
2NDC:65131-097-5213 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/01/2013
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIOperations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-097)

 
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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