Meclizine HCL 25 mg

Drug Labeling and Warnings

Drug Details [pdf]

MECLIZINE HCL 25 MG- meclizine hcl tablet 
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.

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Meclizine HCL 25 mg

Drug Facts

Active ingredient (in each tablet)

Meclizine HCL 25 mg

Purpose

Antiemetic

Uses

  • prevents and treats nausea, vomiting or dizziness due to motion sickness
  • for others uses, consult your doctor

Warnings

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 prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful 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 a Poison Control Center right away.

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

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful 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 a Poison Control Center right away.

Directions

  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other information

  • Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged By: Preferred Pharmaceuticals Inc.

www.reliable1labs.com

NDC: 68788-6451-3

Meclizine HCL 25 mg

ANTIEMETIC

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

*Compare to Active Ingredient in BONINE®

Meclizine HCL 25mg Chewable Tablets
MECLIZINE HCL 25 MG 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-6451(NDC: 69618-028)
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
RASPBERRY (UNII: 4N14V5R27W)  
ASPARTAME (UNII: Z0H242BBR1)  
SUCROSE (UNII: C151H8M554)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorpink (Light Raspberry color) Score2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code AP;115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-6451-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/05/201610/25/2019
2NDC: 68788-6451-525 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 finalpart33608/05/201610/25/2019
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-6451)

Revised: 10/2019