Balminil Expectorant Sugar-Free

In the U.S.

• Allfen
• Altarussin
• Amibid LA
• Antitussin
• Bidex 400
• Diabetic Siltussin DAS-Na
• Diabetic Tussin EX
• Drituss G
• Guaifenex G
• Guaifenex LA
• Mucinex
• Robitussin

In Canada

• Balminil Expectorant
• Balminil Expectorant Sugar-Free
• Benylin-E
• Benylin E Extra Strength Chest Congestion
• Broncho-Grippex Expectorant
• Resyl
• Robitussin Extra Strength

Available Dosage Forms:

• Tablet, Extended Release
• Solution
• Capsule, Extended Release
• Packet
• Liquid
• Tablet
• Capsule
• Elixir
• Syrup

Therapeutic Class: Expectorant

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of guaifenesin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using this medicine in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of guaifenesin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

This section provides information on the proper use of a number of products that contain guaifenesin. It may not be specific to Balminil Expectorant Sugar-Free. Please read with care.

Drinking plenty of water while taking guaifenesin may help loosen mucus or phlegm in the lungs.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole, or open the capsule and sprinkle the contents on soft food such as applesauce, jelly, or pudding and swallow without crushing or chewing.

For patients taking the extended-release tablet form of this medicine:

• If the tablet has a groove in it, you may carefully break it into two pieces along the groove. Then swallow the pieces whole, without crushing or chewing them.
• If the tablet does not have a groove, it must be swallowed whole. Do not break, crush, or chew it before swallowing.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For regular (short-acting) oral dosage forms (capsules, oral solution, syrup, or tablets):
  • For cough:
    • Adults—200 to 400 milligrams (mg) every four hours.
    • Children 6 to 12 years of age—100 to 200 mg every four hours.
    • Children 4 to 6 years of age—50 to 100 mg every four hours.
    • Children and infants up to 4 years of age—Use is not recommended .
• For long-acting oral dosage forms (extended-release capsules or tablets):
  • For cough:
    • Adults—600 to 1200 mg every twelve hours.
    • Children 6 to 12 years of age—600 mg every twelve hours.
    • Children 4 to 6 years of age—300 mg every twelve hours.
    • Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If your cough has not improved after 7 days or if you have a fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness
• headache
• hives
• nausea or vomiting
• skin rash
• stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.