BRONCOCHEM KIDS COLD AND FLU- acetaminophen-phenylephrine hcl-guaifenesin 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

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

With other drugs containing acetaminophen.

Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Uses

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Active Ingredients

Acetaminophen...................325.00mg

Guaifenesin........................200.00mg

Phenylephrine HCl..................5.00mg

Ask a doctor before use if your kid have

Liver disease

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to acetaminophen or any other componet of this formula

Stop use and ask a doctor if

Symtoms last more than 5 days

Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

If your child is taking the bloood thinning drug warfarin

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 inmediately

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 form 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 securety cap is altered or broken

Inactive ingredients

Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

Quiestions?

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

Purose

Acetaminophen...........Analgesic

Guaifenesin................Expectorant

Phenylephrine.............Decongestant

Package principal display panel

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOCHEM  KIDS COLD AND FLU
acetaminophen-phenylephrine hcl-guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-054
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	1.5 mL  in 10 mL
GLYCERIN (UNII: PDC6A3C0OX)	2.5 mL  in 10 mL
SORBITOL (UNII: 506T60A25R)	2 mL  in 10 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	15 mg  in 10 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	20 mg  in 10 mL
DISODIUM HEDTA (UNII: KME849MC7A)	0.9 mg  in 10 mL
POVIDONE K90 (UNII: RDH86HJV5Z)	100 mg  in 10 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR)	40 mg  in 10 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6.25 mg  in 10 mL
HONEY (UNII: Y9H1V576FH)	100 mg  in 10 mL
PROPYL GALLATE (UNII: 8D4SNN7V92)	1 mg  in 10 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.16 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
RASPBERRY (UNII: 4N14V5R27W)	0.0048 mL  in 10 mL
WATER (UNII: 059QF0KO0R)	10 mL  in 10 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-054-18	1 in 1 BOX	05/01/2017
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	05/01/2017

Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)