Drug class
Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Uses
Uses for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness
Warnings
Warnings Do not use for children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contraindications
CONTRAINDICATIONS Neonates and patients with a history of hypersensitivity to dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with dimenhydrinate. Note: This product contains Benzyl Alcohol. Benzyl Alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.
Overdose
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & administration
Directions do not take more than directed to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity to prevent or treat motion sickness, see below: adults and children 12 years and over ■ take 1 to 2 tablets every 4-6 hours ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years ■ give 1/2 to 1 tablet every 6-8 hours ■ do not give more than 3 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years ■ give 1/2 tablet every 6-8 hours ■ do not give more than 1 1/2 tablets in 24 hours, or as directed by a doctor
Active ingredient
Active ingredient (in each tablet) Dimenhydrinate 50 mg
Inactive ingredient
Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Side effects
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The most frequent adverse reaction to dimenhydrinate is drowsiness. Dizziness may also occur. Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.