NDC | 68016-778-02 |
Set ID | 61d29808-e2c0-7f9b-e053-2991aa0a4682 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Consortium, LLC |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
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
• glaucoma
• difficulty urinating due to an enlarged prostate gland
A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
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
I f pregnant or breast-feeding,ask a health professional before use. -
Directions
- to prevent motion sickness, take the first dose one hour before starting activity
- not for frequent or prolonged use except on the advice of a doctor
- do not exceed recommended dose
Adults and children 12
years if age and olderTake 1-2 tablets once daily, or as directed by a doctor.
Do not exceed 2 tablets in 24 hours. - Other information
- Inactive ingredients
- package label
-
INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF
meclizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-778 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color yellow Score no score Shape ROUND Size 9mm Flavor Imprint Code TCL086 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-778-02 1 in 1 CARTON 07/01/2011 1 20 in 1 BOTTLE; 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 07/01/2011 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Geri-Care Pharmaceutical Corp (611196254)