Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir is used as adjunctive therapy in the treatment of irritable bowel syndrome (IBS) and acute enterocolitis*. Donnatal® Elixir is available only by prescription. Your health care provider will determine the individual dose that is right for you depending on your needs based upon your condition, severity of symptoms, and medical history. Donnatal Elixir is prescribed for adults and children. For adults, the usual dosage is 1 or 2 teaspoonfuls, 3 or 4 times a day. For children, the dosage is determined by body weight.
Click here for prescribing information: Donnatal Elixir Prescribing Information
Donnatal® Elixir is a purple colored, grape flavored and/or green colored, mint flavored liquid, in 4 fl oz (118 mL), 10 mL bottles, and 1 pint (473 mL) bottles.
- 4 fl oz (118 mL) bottles “Grape Flavored” NDC 59212-423-04
- 1 Pint (473 mL) bottles “Grape Flavored” NDC 59212-423-16
- 10 mL bottles “Grape Flavored”(single bottle) NDC 59212-423-11
- 12 x 10 mL bottles “Grape Flavored” NDC 59212-423-12
- 4 fl oz (118 mL) bottles “Mint Flavored” NDC 59212-422-04
- 1 Pint (473 mL) bottles “Mint Flavored” NDC 59212-422-16
- 10 mL bottles “Mint Flavored”(single bottle) NDC 59212-422-11
- 12 x 10 mL bottles “Mint Flavored” NDC 59212-422-12
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
- Phenobarbital, USP …………………………….16.2 mg
- Hyoscyamine Sulfate, USP ……………….0.1037 mg
- Atropine Sulfate, USP ………………………0.0194 mg
- Scopolamine Hydrobromide, USP …….0.0065 mg
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Concordia Pharmaceuticals Inc.
St. Michael, Barbados BB11005
IMPORTANT SAFETY INFORMATION
- WHO SHOULD NOT TAKE DONNATAL?
- WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE RECEIVING DONNATAL?
- WHAT ARE THE POSSIBLE SIDE EFFECTS OF DONNATAL?
WHO SHOULD NOT TAKE DONNATAL? DO NOT USE DONNATAL IF YOU HAVE:
- the eye condition called glaucoma
- blockage of the urinary tract
- blockage of the bowel
- been diagnosed with severe ulcerative colitis
- blockage of the intestines
- lack of normal tone or strength of the small bowel if you are elderly or ill
- a problem with your heart, arteries, or veins if you are bleeding
- muscle weakness and fatigue
- problems with your stomach that gives heartburn
- sensitivity or allergic reaction to DONNATAL or any of the ingredients in DONNATAL, or similar drugs (DONNATAL Elixir – mint flavor can cause allergic type reaction in people with aspirin sensitivity)
- a disorder of metabolism called acute intermittent porphyria (that shows as severe stomach pain)
- taken phenobarbital, an ingredient in DONNATAL, and experienced restlessness and/or excitement instead of feeling calm.
WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING DONNATAL?: BEFORE YOU RECEIVE DONNATAL, TELL YOUR HEALTHCARE PROVIDER IF YOU:
- are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. As DONNATAL can cause harm to your baby
- are exposed to high temperatures as DONNATAL can cause overheating
- have diarrhea as it may be an early symptom of other medical problems
- have a stomach ulcer
- experience drowsiness or blurred vision
- take blood thinners
- have a nerve disorder that affects the involuntary body functions
- suffer from kidney or liver disease or liver problems
- have an overactive thyroid
- have heart disease, or have high blood pressure
- have been or are addicted to any medication or have been dependent on drugs (phenobarbital, one of the ingredients in DONNATAL, can be habit forming)
- have bile duct disease
- have an aspirin sensitivity
- have experienced a reaction to DONNATAL or any of its ingredients
WHAT ARE THE SIDE EFFECTS OF DONNATAL? WHEN USING DONNATAL YOU MAY HAVE SIDE EFFECTS.
DONNATAL may cause serious, even life threatening, allergic reactions.
Stop taking DONNATAL and call your healthcare provider right away if you have any signs of a serious allergic reaction including: swelling, particularly of the eyelids, cheeks, or lips, and skin; and inflammation of the skin with redness. Call your healthcare provider if you have any of the following side effects:
dryness of the mouth; difficulty eliminating urine; blurred vision; an increase in heart rate; feeling of heart beating quickly and strongly; widening of the pupil in the eye; difficulty focusing your eye; increased eye tension; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia (inability to fall asleep or to remain asleep); nausea; vomiting; inability in a man to have sexual intercourse; reduced breast milk production; constipation; feeling bloated; muscle and bone pain; severe allergic reaction, including anaphylaxis, and skin reactions; decreased sweating.
Rarely, phenobarbital, an ingredient in DONNATAL, can cause a flaking type of skin reaction that can cause death. This may be associated with fever, changes in behavior, and changes in liver and other internal body parts.
Phenobarbital may produce excitement. In a few cases, anemia (affecting red blood cells) has resulted from long time use of phenobarbital. Seizures and confusion can occur if DONNATAL is stopped suddenly if you are dependent on sedatives such as phenobarbital.
Elderly persons may react with feelings of excitement, agitation, drowsiness, and other ill effects.
The risk information provided here is not comprehensive. To learn more, talk about DONNATAL with your healthcare provider or pharmacist. Click here to obtain the DONNATAL full prescribing information or call Concordia Pharmaceuticals Inc. at 1-877-370-1142.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.