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

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

CAJA BRONCOCHEM KIDS COLD & FLU.jpg

Package Label Principal Display Panel

Etiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpg

BRONCOCHEM  KIDS COLD AND FLU
acetaminophen-phenylephrine hcl-guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-054
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-054-181 in 1 BOX05/01/2017
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2017
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

Revised: 4/2017
Document Id: 7ec85034-cc70-4465-bc25-9c700731eb02
Set id: 523561fb-f6a7-4cde-9be2-bba02e60e208
Version: 1
Effective Time: 20170406
 
LABORATORIO MAGNACHEM INTERNATIONAL SRL