NDC | 54738-025-01, 54738-025-03 |
Set ID | 98e3fe5a-73c6-4dcc-b397-cc6013beee43 |
Category | HUMAN OTC DRUG LABEL |
Packager | Richmond Pharmaceuticals, Inc. |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- Active ingredient
- Purpose
- Uses
For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor
Close - Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an elarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increse drowsiness
- be careful when driving a moor vehicle or operating machinery
- Directions
take dose one hour before travel starts
tablets can be chewed or swallowed whole with water
adults & children 12 years and over:
- take 1-2 tablets once daily
children under 12 years:
- ask a doctor
- Keep out of reach of children.
- OTHER INFORMATION
Phenylketonurics:
Close
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C - Questions or Comments
Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
Close
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING - Inactive ingredients
Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor
Close - Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
MECLIZINE HCL
meclizine hcl 25mg chewable tablets tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-025 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 ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) RASPBERRY (UNII: 4N14V5R27W) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) Product Characteristics Color red Score 2 pieces Shape ROUND Size 8mm Flavor RASPBERRY Imprint Code AP;115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-025-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015 2 NDC:54738-025-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 05/01/2015 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-025)