Blister: 3 years from date of manufacture
Bottle: 5 years from date of manufacture
Croscarmellose sodium, FD&C Yellow #6, lactose, magnesium stearate and microcrystalline cellulose.
Round, orange, flat-faced tablet with beveled-edge, double scored on one side with "APO" over "50".
Diameter: 5/16 FFBE round
Thickness: 0.092" - 0.104"
Blister: Clear film PVC 10ml with silver foil backing.
Carton: Solid bleached stock cardboard 0.16".
75cc HDPE plastic bottle with plastic CR cap (push and twist) and tamper evident seal.
Store at room temperature (15 to 30°C).
For the prevention and treatment of the nausea , vomiting or dizziness associated with motion (travel sickness).
Adults: 1 to 2 tablets every 4 hours as needed, up to 8 tablets in 24 hours.
Children: 6 - 12 years: 1/2 to 1 tablet every 6 - 8 hours as needed, up to 3 tablets in 24 hours.
2 - 6 years: 1/4 to 1/2 tablet every 6 - 8 hours as needed, up to 1 1/2 tablets in 24 hours.
Under 2 years: as directed by a physician. Dosage should be taken at least 30 minutes and preferably 1 or 2 hours, before traveling.
SEE PATIENT INFORMATION PRINTED ON THE INSIDE OF CARTON.
May cause drowsiness. Avoid alcoholic beverages. Do not drive or engage in activities requiring alertness and do not exceed the recommended dosage. Do not take with other antihistamines, tranquilizers or any other sedating drugs without first consulting your physician. Do not take this product if you have glaucoma, chronic lung disease, difficulty in urination due to an enlargement of the prostate gland or if you are pregnant or breastfeeding, unless directed by a physician. This product may cause excitability, especially in children.
May increase gastric degradation of levodopa and decrease amount absorbed by delaying gastric emptying. Therapeutic agents of cholinergic agents and neuroleptics may be antagonized. CNS depressants may increase the degree of sedation and respiratory depression. May increase the absorption of digoxin. Contraindicated in patients with a hypersensitivity to dimenhydrinate or any component. Also contraindicated in patients with glaucoma, chronic lung disease, difficulty in urination due to prostatic hypertrophy.
Hypersensitivity to acetaminophen.
Drowsiness may be experienced by some patients, especially at high dosages. Dizziness may also occur. Symptoms of dry mouth, lassitude, excitement (especially in children) and nausea have been reported, as well as thickening of bronchial secretions, appetite increase, and arthralgia. Children are susceptible to the anticonvulsant action of antihistamines. There have been reports of hallucinations after the ingestion of 500 and 700 mg dimenhydrinate.
Symptoms and Treatment of Overdose:
Symptoms: Drowsiness, ataxia, disorientation, nystagmus, convulsions, stupor, coma and respiratory depression.
Treatment: No specific antidote. Gastric Lavage. If coma and respiratory depression are present, use resuscitative measures, not stimulants. Maintain blood pressure with dopamine or levarterenol bitartrate. It has been reported that anticholinergic induced delirium, confusion, hallucinations, agitation, ataxia, dysarthria and somnolence are reversed by IV or SC administration of 1 to 2 mg physostigmine salicylate.