Robitussin Ac

DRUG DESCRIPTION

Guaifenesin and Codeine

Each 5 ml (1 teaspoonful) contains:

Guaifenesin, USP: 100 mg

Codeine Phosphate, USP: 10 mg

(Warning: May be habit forming)

Alcohol 3.5 percent

In a palatable, aromatic syrup.

Inactive ingredients: (guaifenesin and codeine) Caramel, Citric Acid, FD&C Red 40, Flavors, Glycerin, Saccharin Sodium, Sodium Benzoate, Sorbitol, Water.

What are the possible side effects of codeine and guaifenesin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness or drowsiness;
  • confusion, hallucinations, unusual thoughts or behavior;
  • urinating less than usual or not at all; or
  • slow heart rate, weak pulse, fainting, weak or shallow breathing.

Less serious...

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What are the precautions when taking guaifenesin and codeine (Robitussin Ac)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), heart problems (e.g., irregular heartbeat), kidney disease, liver disease, mental/mood disorders (e.g.,...

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Robitussin Ac Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, facial flushing, nausea, vomiting, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, hallucinations), fast/irregular heartbeat, slow/shallow breathing, trouble urinating.

Seek immediate medical attention if this rare but very serious side effect occurs: seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 side 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), heart problems (e.g., irregular heartbeat), kidney disease, liver disease, mental/mood disorders (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to monitor/avoid these substances in your diet. Consult your doctor or pharmacist about using this medication safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness and drowsiness.

Caution is advised when using this drug in children because they may be more sensitive to the effects of this medicine, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell the doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Robitussin Ac Patient Information Including Side Effects

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, Mar-cof CG, M-Clear WC, Mytussin AC, Robafen AC, Robitussin-AC, Tussiden C, Tussi-Organidin NR, Tussi-Organidin-S NR, Tusso-C

Generic Name: codeine and guaifenesin (Pronunciation: KOE deen and gwye FEN a sin)

  • What is codeine and guaifenesin (Robitussin Ac)?
  • What are the possible side effects of codeine and guaifenesin?
  • What is the most important information I should know about codeine and guaifenesin?
  • What should I discuss with my healthcare provider before taking codeine and guaifenesin?
  • How should I take codeine and guaifenesin?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking codeine and guaifenesin?
  • What other drugs will affect codeine and guaifenesin?
  • Where can I get more information?

What is codeine and guaifenesin (Robitussin Ac)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.

Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of codeine and guaifenesin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

  • severe dizziness or drowsiness;
  • confusion, hallucinations, unusual thoughts or behavior;
  • urinating less than usual or not at all; or
  • slow heart rate, weak pulse, fainting, weak or shallow breathing.

Less serious side effects include:

  • dizziness, drowsiness, headache;
  • warmth, redness, or tingling under your skin;
  • nausea, vomiting, upset stomach;
  • constipation; or
  • 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.

What is the most important information I should know about codeine and guaifenesin?

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

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