ALTIDESP- 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.......................... 50 mg............. Expectorant

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

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not exceed recommended dosage

If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not use this product: for persistent or chrnoic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. 

In a chlid who is taking a prescription Monoaminooxidase Inhibito (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or phamacist before giving this product.

Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.

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 

 Age Dose
 Children 2 years to under 6 years of age1 mL every 4 hours
 Children under 2 years of ageconsult 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.

Inactiveingredients

 calcium saccharin, citric acid, flavors, glycerin, methylparaben, propylene glycol, propylparaben, purified water and sodium citrate

Questions or comments? 1-786-507-1566

Altidesp

ALTIDESP 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-108
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) GUAIFENESIN50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53163-108-0130 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: 20ae625d-ca76-40d2-8cfd-dced5f7058a3
Set id: 21a356f3-e14d-4b6f-9772-a0932ddeb048
Version: 3
Effective Time: 20201223
 
Alternative Pharmacal Corporation