BIOCOTRON PED- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Advanced Generic Corporation

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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Drug Facts

Active Ingredients (in each 5mL)                              Purpose

Dextromethorphan HBr, 15 mg ................................. Cough Suppressant

Guaifenesin, 350 mg ................................................ Expectorant

Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings:

Do no exceed recommended dosage

a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult a doctor

Do not use this product if you

are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

Ask doctor or pharmacist before use if you have

Stop use and ask a doctor if:

Ask a doctor before use if you are taking sedatives or tranquilizers.

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding, ask a doctor before use.

Directions: Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician

AgeDose
Adults and children 12 years of age or older1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of ageAsk a doctor

Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or comments? 1-305-403-3788

biocotronped

BIOCOTRON  PED
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-261
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN350 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-261-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2015
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 465fc4d2-eac7-4b1e-9096-9b2d4f5851fc
Set id: 53097e28-ff2a-4ceb-9c95-d75d7ae511b8
Version: 4
Effective Time: 20201223
 
Advanced Generic Corporation