Label: MOTION SICKNESS RELIEF LESS DROWSY- meclizine hydrochloride tablet
- NDC Code(s): 21130-778-02, 21130-778-22
- Packager: Better Living Brands, 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 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 an enlargement of the prostate gland
- a breathing problems such as emphysema or chronic bronchitis
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful 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
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from heat and humidity
- used by expiration date on package
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gelClose
- Questions of comments?
- Principal Display Panel
COMPARE TO Dramamine® Less Drowsy Formula active ingredient*
Less Drowsy Formula
Motion Sickness Relief
Meclizine HCl 25 mg | Antiemetic
Helps prevent Nausea and
Dizziness due to Motion Sickness
for up to 24 hours
TAMPER EVIDENT: Use Only if This Blister is Intact
*This product is not manufactured or distributed by Prestige Brands, Inc., distributors of Dramamine® Less Drowsy Formula.
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Signature Care 44-403
- INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF LESS DROWSY
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-778 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;403 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-778-22 1 in 1 CARTON 1 32 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:21130-778-02 3 in 1 PACKAGE 2 4 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 06/24/2002 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(21130-778) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(21130-778)