[Sunascen Therapeutics LLC]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Active IngredientsMeclizine HCl 25 mg
Meclizine Hydrochloride is an oral antiemetic. It is a white to slightly yellow crystalline powder which has a slight odor and is tasteless. Meclizine HCl has the following structural formula:
C25H27CIN2 - 2HCI - H2O M.W. 481.89
The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.
Keep out of reach of childrenKeep out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222.
Indications and UseFor the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness
- Not for use in children under 12 years of age unless directed by a doctor.
- Do not take unless directed by a doctor if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland.
- Ask a doctor before use if you are taking sedatives or tranquilizers.
- When using this product:
- Do not exceed the recommended dosage
- May cause drowsiness
- Avoid alcoholic beverages while taking this product
- Alcohol, sedatives and tranquilizers may increase drowsiness
- Use caution when driving or operating machinery
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222
Adults and children 12 years of age and over: Oral dosage is 1 to 2 film strips (25 to 50mg) once daily, or as directed by a physician. Place 1 to 2 film strips on the tongue to completely dissolve then swallow.
- polyethylene oxide
- hydroxypropyl methylcellulose
- acesulfame potassium
- citric acid
- sodium citrate
Principal Display PanelMeclizine HCl Film Strips, 25 mg Each
Antiemetic – Prevent and Treat: Nausea and Vomiting
Distributed by: Sunascen Therapeutics LLC
Rockville, MD 20850 USA
TAMPER EVIDENT: EACH FILM STRIP IS INDIVIDUALLY SEALED IN A POUCH. DO NOT USE IF INDIVIDUAL POUCH IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING.
Store at controlled room temperature 20-30°C. (68-86°F)
Protect from heat and humidity
Use by expiration date on package
NAUS-EASE 8 Film Strips: NDC 49467-104-01
NAUS-EASE 16 Film Strips: NDC 49467-104-16
meclizine hydrochloride film, soluble
|Labeler - Sunascen Therapeutics LLC (078272834)|