![MECLIZINE 25 (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/cf79ac74-017e-4fb4-85d3-4ea944080e89/43063804.jpg)
| NDC | 43063-804-01, 43063-804-06, 43063-804-12, 43063-804-20, 43063-804-30 |
| Set ID | cf79ac74-017e-4fb4-85d3-4ea944080e89 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | PD-Rx Pharmaceuticals, Inc. |
| Generic Name | |
| Product Class | Antiemetic |
| Product Number | |
| Application Number | PART336 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each chewable tablet)
- Purpose
- Indications and Usage
- Warnings
- Do not use for children under 12 years of age unless directed by a doctor.
Do not take unless directed by a doctor if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
CloseKeep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
- Directions
Dosage should be taken 1 hour befor travel starts.
CloseAdults and children 12 years and over: Take 1 or 2 tablets once daily, or as directed by doctor. - Inactive ingredients
Croscarmellose sodium, dextrose, FD& C Red #40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid
Close - Questions?
- How Supplied
Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.
Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.
Close - PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
AntiemeticEach chewable tablet contains:
Meclizine HCl
25 mgStore at 68°-77°F (20°-25°C)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Close
- INGREDIENTS AND APPEARANCE
MECLIZINE 25
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-804 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 MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code PH;051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-804-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/27/2017 11/30/2027 2 NDC:43063-804-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018 11/30/2027 3 NDC:43063-804-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/08/2018 11/30/2027 4 NDC:43063-804-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2018 11/30/2027 5 NDC:43063-804-06 6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/23/2018 11/30/2027 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/27/2017 11/30/2027 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) CloseEstablishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-804)