Label: VERTICALM - meclizine hydrochloride tablet
- NDC Code(s): 52389-623-24
- Packager: Alva-Amco Pharmacal Companies, Inc.
- 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 ingredient (in each tablet)
Meclizine hydrochloride, 25 mgClose
For the prevention and treatment of
- dizziness associated with motion sickness
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
When using this product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
- PREGNANCY OR BREAST FEEDING
If pregnant or breastfeeding, ask a health professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Close
- Read all package directions and warnings before use.
- Use only as directed.
- Adults: Swallow one (1) or two (2) tablets with water once daily or as directed by a doctor.
- For use by normally healthy adults only.
- Persons under 18 years of age should use only as directed by a doctor.
- If you experience continuous or recurring symptoms, check with your doctor for appropriate diagnosis and treatment.
- Other information
- **Contents sealed: Each Verticalm yellow, round shaped tablet bears the identfying mark "ALVA", and is sealed in a clear plastic blister with a foil backing.
- Do not use if seal appears broken or if product contents do not match product description.
- You may report serious side effects to the phone number provided under Questions? below.
- Inactive ingredients
Corn starch, croscarmellose sodium, D&C Yellow No. 10 Lake, lactose, magnesium stearate, microcrystalline cellulose, silica, stearic acid.Close
- INGREDIENTS AND APPEARANCE
meclizine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-623 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 STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Lactose (UNII: J2B2A4N98G) Magnesium stearate (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Silicon dioxide (UNII: ETJ7Z6XBU4) Stearic acid (UNII: 4ELV7Z65AP) Product Characteristics Color yellow (yellow) Score no score Shape ROUND Size 9mm Flavor Imprint Code ALVA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-623-24 1 in 1 CARTON 1 24 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 04/16/2012 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)