PANATUSS PED- chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops 
Seyer Pharmatec, Inc.

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                         Purpose
(in each 1 mL)

Chlophedianol HCl 6.25 mg ...................... Cough Suppressant

Dexchlorpheniramine Maleate 0.5 mg ......... Antihistamine

Pseudoephedrine HCl 15 mg ................... Nasal Decongestant

Purpose

Cough Suppressant

Antihistamine

Nasal Decongestant

Uses

Temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold

  • calms the cough control center and relieves coughing
  • non narcotic cough suppressant for the temporary relief of cough
  • temporarily relieves runny nose and alleviates sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other upper respiratory allergies
  • temporarily relieves nasal congestion due to the common cold
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

  • do not exceed recommended dosage
  • a persistent 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
Ask a doctor before use if a child has
  • a persistent or chronic cough such as occurs with asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
Ask a doctor before use if a child is taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase the drowsiness effect


Do not use

  • in a child who 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 contains an MAOI, ask a doctor or pharmacist before taking this product
Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • if symptoms do not improve within 7 days or are accompanied by fever, rash or persistent headache.

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

Directions

  • take every 6 hours, not to exceed 4 doses in 24 hours or as directed by a physician

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

Inactive ingredients

Citric acid, flavor, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

Questions or comments?1-888-782-3585

panatusspeddrops

PANATUSS PED 
chlophedianol hydrchloride, dexchlorpheniramine maleate, pseudoephedrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2785
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE6.25 mg  in 1 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE0.5 mg  in 1 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (Tropical Fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11026-2785-21 in 1 CARTON12/15/201202/28/2021
160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/15/201202/28/2021
Labeler - Seyer Pharmatec, Inc. (832947126)

Revised: 10/2021
 
Seyer Pharmatec, Inc.