Label: NAUS-EASE - meclizine hydrochloride film, soluble
- NDC Code(s): 49467-104-01, 49467-104-16
- Packager: Sunascen Therapeutics LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Meclizine 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 children
Keep 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 Use
For 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.Close
- Inactive Ingredients
- polyethylene oxide
- hydroxypropyl methylcellulose
- acesulfame potassium
- citric acid
- sodium citrate
- Principal Display Panel
Meclizine 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
- INGREDIENTS AND APPEARANCE
meclizine hydrochloride film, soluble
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49467-104 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTITOL (UNII: D65DG142WK) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) Product Characteristics Color green Score no score Shape RECTANGLE Size 22mm Flavor LIME Imprint Code S1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49467-104-01 8 in 1 CARTON 1 1 in 1 POUCH 2 NDC:49467-104-16 16 in 1 CARTON 2 1 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 04/16/2012 Labeler - Sunascen Therapeutics LLC (078272834)