Label: MECLIZINE - meclizine hcl tablet
- NDC Code(s): 10267-3206-1, 10267-3206-4
- Packager: Contract Pharmacal Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 26, 2011
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- SPL UNCLASSIFIED SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- Active ingredient
(in each tablet)
Meclizine HCl 25 mgiClose
for the prevention and treatment of the nausea, vomiting, dizziness associated with motion sicknessClose
Do not use
- In children under 12 years of age unless directed by a doctor
- Ask a doctor before use if you have
- breathing problems such as emphysema or chronic bronchitis
- difficulty in urination due to enlarged prostate gland
- Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizersClose
- When using this product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- If pregnant or breast-feeding,
ask a health care professional before use.Close
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
- To prevent motion sickness, the first dose should be taken one hour before starting activity.
- Adults and children 12 years of age and over: chew 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor.
DO NOT EXCEED RECOMMENDED DOSE
- Store at room temperature, USP
- Inactive ingredient
Corn Starch, Croscarmellose Sodium, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10267-3206 Route of Administration ORAL 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) FD&C RED NO. 40 (UNII: WZB9127XOA) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) RASPBERRY (UNII: 4N14V5R27W) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) VANILLA (UNII: Q74T35078H) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 258 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10267-3206-1 100 in 1 BOTTLE 2 NDC:10267-3206-4 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part336 07/24/2001 Labeler - Contract Pharmacal Corp (968334974) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corp 968334974 MANUFACTURE