chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride

chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride by

Drug Labeling and Warnings

chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE- chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid 
Westminster Pharmaceuticals, LLC

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chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride

Drug Facts

Active ingredients (in each 5 mL teaspoonful)Purpose
Chlophedianol Hydrochloride 12.5 mgCough Suppressant
Dexchlorpheniramine Maleate 1 mgAntihistamine
Pseudoephedrine Hydrochloride 30 mgNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces congestion
  • reduces swelling of nasal passages

Warnings

Do not exeed recommended dosage.

Do not use this product

  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor before use 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 the drowsiness effect
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, diziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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

Keep out of reach of children.

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

Directions

Do not exceed recommended dosage.

adults and children 12 years of age and over:2 teaspoonfuls every 6 hours, not to exeed 8 teaspoonfuls in 24 hours.
children 6 to under 12 years of age:1 teaspoonful every 6 hours, not to exeed 4 teaspoonfuls in 24 hours.
children under 6 years of age:consult a doctor

Other Information

  • Store at room temperature 68°-86°F (20°-30°C) with excursions of 59°-86°F (15°-30°C)

Inactive ingredients

citric acid anhydrous, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

Questions or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 69367-183-16

Chlophedianol HCl,
Dexchlorpheniramine
Maleate and
Pseudoephedrine HCl

Cough Suppressant
Antihistamine
Nasal Decongestant

Sugar Free, Alcohol Free,
Dye Free

Tutti Frutti Flavor

EACH 5 mL (1 TEASPOONFUL) CONTAINS:
Chlophedianol Hydrochloride   12.5 mg
Dexchlorpheniramine Maleate   1 mg
Pseudoephedrine Hydrochloride   30 mg

16 fl. oz. (473 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE 
chlophedianol hydrochloride, dexchlorpheniramine maleate, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69367-183
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69367-183-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/202110/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01207/29/202110/01/2024
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 7/2021
Document Id: 96d9744b-983e-49ca-8be6-0d2fa89a8e4f
Set id: 7e3b8a3d-f80c-4379-abde-cfac8308580c
Version: 3
Effective Time: 20210729