Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine

Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine

March 21, 2017

Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine oral solution or syrup

What is Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine oral solution or syrup?

HYDROCODONE; POTASSIUM GUAIACOLSULFONATE; PSEUDOEPHEDRINE (Protuss®-D Liquid) helps to stop or reduce coughing and nasal congestion (stuffiness) due to the common cold or respiratory infections. Federal law prohibits the transfer of hydrocodone to any person other than the patient for whom it was prescribed. Do not share this medicine with anyone else. Generic hydrocodone; potassium guaiacolsulfonate; pseudoephedrine oral syrup is available.

What should my health care professional know before I receive Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine?

They need to know if you have any of these conditions:

  • asthma or breathing problems

  • blood vessel disease

  • chronic bronchitis

  • constipation or diarrhea

  • diabetes

  • emphysema or other lung disease

  • fever

  • glaucoma

  • heart disease or heart rhythm problems

  • high blood pressure

  • intestinal or stomach problems

  • kidney disease

  • liver disease

  • other chronic illness

  • over active thyroid

  • pain or difficulty passing urine

  • peripheral vascular disease

  • prostate trouble

  • recent head trauma

  • smoker

  • an allergic or unusual reaction to codeine, hydrocodone, hydromorphone, oxycodone, morphine, potassium guaiacolsulfonate, pseudoephedrine, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should this medicine be used?

Take hydrocodone; potassium guaiacolsulfonate; pseudoephedrine oral syrup by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one; household spoons are not always accurate. Take hydrocodone; potassium guaiacolsulfonate; pseudoephedrine with food or milk if it upsets your stomach. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not share this medicine with anyone.

Take hydrocodone; potassium guaiacolsulfonate; pseudoephedrine with a full glass of water to help loosen and clear mucus from your throat.

Elderly patients over 60 years old may have a stronger reaction to this medicine.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If it is almost time for your next dose (less than 2 hours), take only that dose. Do not take double or extra doses. Each dose of this cough medicine should be taken at least 4 hours apart. Do not take more frequently than how it was prescribed by your health care professional.

What drug(s) may interact with Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine?

  • alcohol and alcohol-containing medicines

  • amphetamine or other stimulant drugs

  • bicarbonate, citrate, or acetate products (such as sodium bicarbonate, sodium acetate, sodium citrate, sodium lactate, and potassium citrate)

  • caffeine

  • chloroquine

  • certain medicines used for pain

  • certain medicines used for Parkinson's disease

  • cimetidine

  • furazolidone

  • linezolid

  • medicines for diabetes

  • medicines for diarrhea

  • medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)

  • medicines used for depression or psychosis

  • medicines used for sleep or anxiety

  • procarbazine

  • quinacrine

  • rifabutin

  • rifampin

  • ritonavir

  • seizure medications

  • some antihistamines

  • some medicines for chest pain, heart disease, high blood pressure or heart rhythm problems

  • some medicines for weight loss (including some herbal products, ephedrine, dextroamphetamine)

  • St. John's wort

  • theophylline

  • thyroid hormones

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine?

Tell your prescriber or health care professional if your cough does not improve in 7 days. If you have a high fever, skin rash, or persistent headache as well as a cough, see your prescriber or health care professional.

Use exactly as directed by your prescriber or health care professional. If you are taking hydrocodone; potassium guaiacolsulfonate; pseudoephedrine on a regular basis, do not suddenly stop taking it. Your prescriber may want to slowly lower your dose.

You may get drowsy or dizzy when you first start taking this medicine. Be careful taking other medications that may also make you tired. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Stand or sit up slowly to reduce the risk of dizzy or fainting spells. The drowsiness should decrease after taking this medicine for a couple of days. Alcohol can increase the possible drowsiness, dizziness or confusion from this medicine. Do not drink alcoholic beverages while taking this medicine.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard candy may help to relieve dry mouth symptoms. Also, this medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your ophthalmologist if the problem does not go away or is severe.

This cough medicine may cause constipation. You may need to take a laxative and/or a stool softener. Try to have a bowel movement at least every 2—3 days. If you do not have a bowel movement for 3 days or more call your prescriber or health care professional. They may recommend using an enema or suppository to help you move your bowels.

If this medicine makes it difficult for you to sleep at night; take your last dose at least 2 hours before bedtime. If nervousness, dizziness, or sleeplessness occur, stop using this medicine and consult your health-care provider.

If you are going to have surgery, tell your prescriber or health care professional that you are taking this medicine.

What side effects may I notice from receiving Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

  • chest pain, palpitations

  • confusion

  • decreased ability to pass urine

  • difficulty breathing

  • fainting spells, or dizziness which does not go away

  • numbness or tingling in the hands or feet

  • persistent or unusual rash

  • severe, persistent, or worsening headache

More common:

  • anxiety or nervousness

  • blurred vision

  • fast, slow, or irregular heartbeat

  • increased blood pressure

  • excessive sweating

  • sleeplessness (insomnia)

  • tremor or muscle contractions

  • vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • constipation or diarrhea

  • drowsiness

  • dry mouth

  • headache (mild)

  • itching

  • stomach upset, nausea

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open. Avoid accidental swallowing of hydrocodone; potassium guaiacolsulfonate; pseudoephedrine by someone (especially children) other than the person for whom it was prescribed as this may result in severe effects and possibly death.

Store at room temperature, between 15—30 degrees C (59—86 degrees F); do not freeze. Keep the container tightly closed and protect from light. Throw away any unused medicine after the expiration date.


March 21, 2017


U.S. FDA-approved Package Insert