Label: MECLIZINE 25- meclizine hydrochloride tablet, chewable
- NDC Code(s): 43063-804-01, 43063-804-12, 43063-804-20, 43063-804-30
- Packager: PD-Rx Pharmaceuticals, 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 March 15, 2018
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- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each chewable tablet)
Meclizine 25 mgClose
- Indications and Usage
prevents and treats nausea, vomiting, dizziness associated with motion sickness:Close
- 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
- 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Dosage should be taken 1 hour befor travel starts.
Adults 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 acidClose
Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).Close
- How Supplied
Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.
Supplied in bottles of 12 , 20, 30 and 100 chewable tablets.Close
- PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
Each chewable tablet contains:
Store at 68°-77°F (20°-25°C)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
- INGREDIENTS AND APPEARANCE
meclizine hydrochloride tablet, chewable
Product 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 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) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-804)