Consists of chlorphenamine maleate, Phenylephrine hydrochloride
Side effects of Chlorphenamine maleate (Duro-Tuss Cold & Allergy) in details
Drowsiness, dizziness, headache, constipation, stomach upset, blurred vision, decreased coordination, or dry mouth/nose/throat may occur. These effects may decrease as your body adjusts to the medication. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. Chlorpheniramine can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.
If you are using a sustained-release product, an empty tablet shell may appear in your stool. This is harmless.
If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, irritability, nervousness, confusion), ringing in the ears, trouble urinating.
Tell your doctor right away if any of these rare but very serious side effects occur: easy bruising/bleeding, fast/irregular heartbeat, seizure.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Chlorphenamine maleate (Duro-Tuss Cold & Allergy) contraindications
Injection: Chlorphenamine maleate (Duro-Tuss Cold & Allergy) is contraindicated in comatose states, in patients who have received large amounts of central-nervous-system depressants (alcohol, sedative hypnotics, including barbiturates, general anesthetics, narcotics, narcotic analgesics, tranquilizers, etc.), and in patients who have demonstrated an idiosyncrasy or hypersensitivity to promethazine.
Under no circumstances should promethazine be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene
Chlorphenamine maleate (Duro-Tuss Cold & Allergy) HCl injection should not be given by the subcutaneous route; evidence of chemical irritation has been noted, and necrotic lesions have resulted on rare occasions following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.
Syrup, Tablets and Suppositories: Phenergan Tablets and Suppositories are contraindicated for use in pediatric patients less than two years of age.
Phenergan Tablets and Suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
What are the possible side effects of Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy)?
Get emergency medical help if you have any of these signs of an allergic reaction to Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) and call your doctor at once if you have:
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fast, pounding, or uneven heartbeat;
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severe dizziness or anxiety;
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easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
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dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).
Common Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) side effects may include:
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loss of appetite;
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warmth, tingling, or redness under your skin;
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feeling restless or excited (especially in children);
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sleep problems (insomnia); or
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skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) in details
The following serious adverse reactions are described below and elsewhere in the labeling:
- Cardiovascular Effects
- Elevation in Blood Pressure
The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ocular Adverse Reactions
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
Systemic Adverse Reactions
A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.
Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
What is the most important information I should know about Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy)?
- Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy). Using Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
- If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy).
- Do not take diet or appetite control medicines while you are taking Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy).
- Phenylketonuria patients - Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) may contain phenylalanine.
- Diabetes patients - Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Use Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) with caution in the ELDERLY because they may be more sensitive to its effects.
- Use Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) during pregnancy. It is unknown if Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) is excreted in breast milk. If you are or will be breast-feeding while you are using Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy), check with your doctor or pharmacist to discuss the risks to your baby.
When used for long periods of time or at high doses, some people develop a need to continue taking Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy). This is known as DEPENDENCE or addiction. If you are addicted and suddenly stop taking Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy), you may experience WITHDRAWAL symptoms, including depression.
Phenylephrine hydrochloride (Duro-Tuss Cold & Allergy) contraindications
Cardiac and Endocrine Disease
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
Pediatric Patients Less Than 1 Year of Age
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
References
- DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Chlorphenamine hydrogen maleate: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Phenylephrine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology