ALTICOTRON- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops 
Alternative Pharmacal 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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Active Ingredients (in each 1 mL)                Purpose

Dextromethorphan HBr............ 5 mg............. Cough Suppressant

Guaifenesin.......................... 100 mg............. Expectorant

Phenylephrine HCl................ 2.5 mg.............. Nasal Decongestant 

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

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

DO NOT USE

If a child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if the child has:

When using this product do not exceed recommended dosage.

Stop use and ask a doctor before use if:

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

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

Directions 

Children 6 years to under 12 years of age 2 ml 
 Children 2 years to under 6 years of age Ask a doctor
 Children under 2 years of ageAsk a doctor

Other Information

Store at room temperature 150 - 300C (590-860F)

Tamper Evident Feature: Do not use if seal is torn, broken or missing. Avoid excessive heat or humidity.

Inactiveingredients

 citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Questions or comments? 1-786-507-1566

AlticotronAlticotron

ALTICOTRON 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:53163-107-0260 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 - Alternative Pharmacal Corporation (078528214)

Revised: 12/2020
Document Id: 80f5ea58-2833-47da-9e09-c1e56d2c994f
Set id: 09a7cf20-d48e-401d-9d6a-01ec16b5d277
Version: 4
Effective Time: 20201223
 
Alternative Pharmacal Corporation