BRONCOCHEM ALLERGY CONTROL- cholpheniramine maleate-phenylephrine hcl 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 ALLERGY CONTROL

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.

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

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PAKAGE LABEL.PRINCIPAL DISPLAY PANEL

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BRONCOCHEM  ALLERGY CONTROL
cholpheniramine maleate-phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-098
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-098-471 in 1 BOX04/01/2017
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 finalpart34104/01/2017
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-098)

Revised: 3/2017
Document Id: 8ddc705a-c6b4-4b03-8492-d2b00eaa4b88
Set id: ec5a216c-6827-4de3-8683-ff04e726ff6f
Version: 1
Effective Time: 20170314
 
LABORATORIO MAGNACHEM INTERNATIONAL SRL