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

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

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

BAG IMAGE

BOX IMAGE

BOX IMAGE 

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-097
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 13 g
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 13 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (FD&C YELLOW NO.5)	Score
Shape		Size
Flavor	LIME (LIME (CITRUS))	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-097-53	6 in 1 BOX	09/28/2017
1	NDC: 65131-097-52	13 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 65131-097-12	25 in 1 BOX	09/28/2017
2	NDC: 65131-097-52	13 g in 1 PACKAGE; 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	09/01/2013

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(65131-097)