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Endal CD Syrup

Generic Name: chlorpheniramine maleate, codeine phosphate, phenylephrine hydrochloride
Dosage Form: oral liquid

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.

Endal CD

Active Ingredients (in each 5 mL)

Chlorpheniramine maleate 2 mg
Codeine phosphate* 7.5 mg
*WARNING: MAY BE HABIT-FORMING
Phenylephrine HCl 5 mg

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Purpose

Antihistamine
Cough Suppressant
Nasal Decongestant

Uses

  • Temporarily relieves runny nose and relieves sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies (allergic rhinitis).
  • For the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
  • Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.
  • Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.
  • Controls the impulse to cough to help you sleep.
  • Calms the cough control center and relieves coughing.

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 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.

Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, unless directed by a doctor.

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

When using this product

  • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

A persistent cough may be a 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.

May cause or aggravate constipation.

May cause excitability, especially in children.

Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor.

If pregnant or breast-feeding,

ask a health professional before use.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, seek professional assistance, or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and over: 10 mL every 4 hours, not to exceed 6 doses (60 mL) in a 24 hour period.
Children 6 to under 12 years of age: 5 mL every 4 hours, not to exceed 6 doses (30 mL) in a 24 hour period.
Children under 6 years of age: Consult a physician.

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other Information

Store at 20°-25°C (68°-77°F).

Inactive Ingredients

cherry flavor, citric acid, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

Questions? Comments?

Call (866) 417-9669

ENDAL CD 
chlorpheniramine maleate, codeine phosphate, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23589-076
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg  in 5 mL
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 7.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
PROPYLENE GLYCOL  
WATER  
SODIUM CITRATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:23589-076-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/28/2011 04/30/2013
Labeler - Tiber Laboratories, LLC (008913939)
Revised: 11/2011
 
Tiber Laboratories, LLC



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