Label: LESS DROWSY MOTION SICKNESS RELIEF- meclizine hcl tablet
- NDC Code(s): 49035-403-19, 49035-403-40
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 14, 2018
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- Active ingredient (in each tablet)
Meclizine HCl 25 mgClose
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sicknessClose
Ask a doctor before use if you have
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- to prevent motion sickness, take the first dose one hour before starting activity
- to prevent or treat motion sickness: 1 to 2 tablets once daily for adults and children 12 years and over, or as directed by a doctor
- Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OF BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from heat and humidity
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gelClose
- Questions or comments?
- Principal Display Panel
Meclizine HCl 25 mg,
• Helps prevent nausea and dizziness
due to motion sickness
mg 8 TABLETS
Distributed by: Walmart Inc., Bentonville, AR 72716
PRODUCT OF INDIA
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
LESS DROWSY MOTION SICKNESS RELIEF
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-403 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color YELLOW Score no score Shape ROUND Size 9mm Flavor Imprint Code 44;403 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-403-19 1 in 1 CARTON 06/24/2002 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49035-403-40 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/24/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 06/24/2002 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(49035-403) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(49035-403) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(49035-403)