MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable 
RPK Pharmaceuticals, Inc.

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Meclizine HCl 25 mg Chewable Tablets

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Directions

  • 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

  • phenylketonurics: contains phenylalanine 0.28 mg per tablet
  • store at room temperature in a dry place

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.

Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

HOW SUPPLIED

Product: 53002-7650

NDC: 53002-7650-1 10 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7650-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7650-3 30 TABLET, CHEWABLE in a BOTTLE

Meclizine 25mg Chewtabs

Label Image
MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53002-7650(NDC:51645-994)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (Uncoated) Score2 pieces
ShapeROUND (Biconvex) Size8mm
FlavorRASPBERRYImprint Code 21G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53002-7650-110 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201812/31/2021
2NDC:53002-7650-220 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201812/31/2021
3NDC:53002-7650-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/201812/31/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00910/15/201512/31/2021
Labeler - RPK Pharmaceuticals, Inc. (147096275)
Establishment
NameAddressID/FEIBusiness Operations
RPK Pharmaceuticals, Inc.147096275RELABEL(53002-7650) , REPACK(53002-7650)

Revised: 6/2024
 
RPK Pharmaceuticals, Inc.