BRONCOCHEM ALLERGY CONTROL- cholpheniramine maleate-phenylephrine hcl syrup

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

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI) If you are uncertain whether your prescription contains MAOI ask a doctor or oharmacist before taking this product.

Uses

Nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic rhinitis.

PURPOSE

Active ingredients (in 10 mL or cc)

Chlorpheniramine Maleate.......4.00mg (antihistamine)

Phenylephrine HCl..................5.00mg (Decongestant)

Ask a doctor or Pharmacist if you

Are taking sedatives or tranquilizers

When Using this Product

Excitability may occur, especially in children.

May cause marked drowsiness

Avoid alcoholic drinks

Alcohol, sedatives and tranquilizers may increase drowsiness

Be careful when driving or operating machinery

Stop Use and Ask a Doctor If

Nervousness, dizziness or sleeplessness occur.

Symptoms last more than five days.

If fever is presented that last more than 3 days or headache appers, this could be signs of a serious condition.

Keep Out of the Reach of children

Keep out of the reach of children.

If pregnant or breast-feeding, ask a doctor before taking this product.

Overdose warning

In case of accidental overdose, seek professional assistance or contact a poison control center inmediately.

Directions

Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24-hour period.

Adults and Children from 12 years above 10mL or cc every 6 hours.

Children from 6 to 12 years 5mL or cc every 6 hours.

Children under 6 years, ask your doctor.

Other Information

Store at 66-77

Inactive Ingredients

Propylene glycol, Glicerin, Sorbitol 70% USP, sucralose, Povidone, Sodium chloride, Aloe Vera, Metil paraben USP, Propil paraben USP, Propyl gallate, Citric acid, Sodium citrate dihydrate, EDTA disodium, Grape flavor, Purified water.

Questions

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

Made in Dominican Republic by Laboratorio Magnachem International SRL to Global Corporation Inc. Boca Raton, Fl 33487

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOCHEM  ALLERGY CONTROL
cholpheniramine maleate-phenylephrine hcl syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1.2 mL  in 10 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 10 mL
SORBITOL (UNII: 506T60A25R)	2 mL  in 10 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	7.5 mg  in 10 mL
POVIDONE K90 (UNII: RDH86HJV5Z)	100 mg  in 10 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6.25 mg  in 10 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	4 mg  in 10 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	10 mg  in 10 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	1.5 mg  in 10 mL
PROPYL GALLATE (UNII: 8D4SNN7V92)	1 mg  in 10 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU)	20 mg  in 10 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	40 mg  in 10 mL
EDETATE SODIUM (UNII: MP1J8420LU)	0.9 mg  in 10 mL
GRAPEFRUIT (UNII: O82C39RR8C)	0.0048 mL  in 10 mL
WATER (UNII: 059QF0KO0R)	10 mL  in 10 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-098-47	1 in 1 BOX	04/01/2017
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2017

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(65131-098)