Label: MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable
- NDC Code(s): 68788-6944-3, 68788-6944-5
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 51645-994
- 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 November 30, 2018
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- Active ingredient (in each chewable tablet)
Meclizine HCl, USP 25 mgClose
prevents and treats nausea, vomiting or dizziness due to motion sicknessClose
- DO NOT USE
Do not use in children under 12 years of age unless directed by a doctor.Close
- ASK DOCTOR
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before useClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
In case of overdose, get medical help or contact the poison control center immediately.Close
- Dosage should be taken one hour before travel starts.
- Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
- Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.
- Other information
- store at room temperature
- OTHER SAFETY INFORMATION
- Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
- Do not use if imprinted safety seal under cap is broken or missing
- Inactive ingredients
aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.Close
- Questions or comments?
If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.Close
- SPL UNCLASSIFIED SECTION
Distributed by: Plus Pharma, Commack, NY 11725
*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.Close
- WHEN USING
When using this product
- may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- use caution when driving a motor vehicle or operating machinery
- PRINCIPAL DISPLAY PANEL
Meclizine HCl 25 mg
Treats and Prevents Motion Sickness
Prevents nausea, dizziness and vomiting
*Compare to the Active Ingredient in Bonine®
30 CHEWABLE TABLETS25 mg each
Repackaged By: Preferred Pharmaceuticals Inc.Close
- INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6944(NDC:51645-994) 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) SUCROSE (UNII: C151H8M554) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color pink (Uncoated) Score 2 pieces Shape ROUND (Biconvex) Size 8mm Flavor RASPBERRY Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-6944-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2017 2 NDC:68788-6944-5 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 04/17/2017 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6944)