Meclizine HCl 25 mg Chewable Tablets

Drug Labeling and Warnings

Drug Details [pdf]

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

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.

----------

Meclizine HCl 25 mg Chewable Tablets

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.

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

  • store at room temperature

  • 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.

Questions or comments?

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®.

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

NDC: 68788-6944-3

Plus Pharma

Meclizine HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

Prevents nausea, dizziness and vomiting

*Compare to the Active Ingredient in Bonine®

Raspberry

30 CHEWABLE TABLETS25 mg each

Repackaged By: Preferred Pharmaceuticals Inc.

Meclizine HCL 25mg Chewable Tablets
MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-6944(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: 68788-6944-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/201710/25/2019
2NDC: 68788-6944-525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/201710/25/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33604/17/201710/25/2019
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-6944)

Revised: 10/2019
 
Preferred Pharmaceuticals Inc.