BRONCOCHEM COLD AND FLU TEA- acetaminophen-phenylephrine hydrochloride-chlorpheniramine maleate granule, for solution 
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 COLD AND FLU TEA

Warnings

Liver warning:

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

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

BAG IMAGE

PAPERBRONCOCHEM COLD AND FLUTEA.jpg

BOX IMAGE

BCFTEABOX25.jpg

BOX IMAGE 

BCFTEABOX.jpg

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 13 g
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 13 g
Inactive Ingredients
Ingredient NameStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) 10 mg  in 13 g
ASCORBIC ACID (UNII: PQ6CK8PD0R) 66 mg  in 13 g
SUCROSE (UNII: C151H8M554) 9483 mg  in 13 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1500 mg  in 13 g
HONEY (UNII: Y9H1V576FH) 100 mg  in 13 g
MALTODEXTRIN (UNII: 7CVR7L4A2D) 1000 mg  in 13 g
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) 166.6 mg  in 13 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 28.43 mg  in 13 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 40 mg  in 13 g
PROPYL GALLATE (UNII: 8D4SNN7V92) 0.433 mg  in 13 g
ALCOHOL (UNII: 3K9958V90M) 0.001 mL  in 13 g
Product Characteristics
Coloryellow (FD&C YELLOW NO.5) Score    
ShapeSize
FlavorLIME (LIME (CITRUS)) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-097-536 in 1 BOX09/28/2017
1NDC:65131-097-5213 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:65131-097-1225 in 1 BOX09/28/2017
2NDC:65131-097-5213 g in 1 PACKAGE; Type 0: Not a Combination Product
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/FEIBusiness Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-097)

Revised: 12/2019
Document Id: 6634cf8a-9769-40ea-9da6-b56f00d1013d
Set id: b7d3f54e-59ef-4b85-a88d-b053058dc1f6
Version: 10
Effective Time: 20191212
 
LABORATORIO MAGNACHEM INTERNATIONAL SRL