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BRONCOCHEM KIDS COLD AND FLU

Medically reviewed on April 6, 2017

Dosage form: syrup
Ingredients: ACETAMINOPHEN 325mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL, GUAIFENESIN 200mg in 10mL
Labeler: LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC Code: 65131-054

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.

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

Package Label Principal Display Panel

BRONCOCHEM  KIDS COLD AND FLU
acetaminophen-phenylephrine hcl-guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-054
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL1.5 mL  in 10 mL
GLYCERIN2.5 mL  in 10 mL
SORBITOL2 mL  in 10 mL
SUCRALOSE15 mg  in 10 mL
CITRIC ACID MONOHYDRATE20 mg  in 10 mL
DISODIUM HEDTA0.9 mg  in 10 mL
POVIDONE K90100 mg  in 10 mL
SODIUM CITRATE40 mg  in 10 mL
SODIUM CHLORIDE6.25 mg  in 10 mL
HONEY100 mg  in 10 mL
PROPYL GALLATE1 mg  in 10 mL
FD&C RED NO. 400.16 mg  in 10 mL
ALOE VERA LEAF4 mg  in 10 mL
METHYLPARABEN10 mg  in 10 mL
PROPYLPARABEN1.5 mg  in 10 mL
RASPBERRY0.0048 mL  in 10 mL
WATER10 mL  in 10 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65131-054-181 BOTTLE, PLASTIC in 1 BOX
1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2017
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

 
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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