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  5. Label Information: Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride

FDA Label for Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



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

Otc - Ask Doctor/Pharmacist



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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 01

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - chlophedianol 01


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