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

----------

Meclizine Hydrochloride Chewable Tablets 25 mg

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 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 0.0025 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

Inactive ingredients

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions or comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.
Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine®

Manufactured by: 
Unique Pharmaceutical Laboratories
(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Mfg. Lic. No.: G/1430
Feb 2022

Repackaged By: Preferred Pharmaceutical Inc.

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

68788-8529

Meclizine HCL 25mg Chewable Tablets
MECLIZINE HCL 
meclizine hydrochloride chewable tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8529(NDC:16571-824)
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)  
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)  
RASPBERRY (UNII: 4N14V5R27W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
Colorpink (Pink to light pink) Score2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-8529-110 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
2NDC:68788-8529-330 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug33610/06/2023
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-8529)

Revised: 10/2023
Document Id: a7f3f32a-0651-4e55-ac51-c85a23352a24
Set id: a7f3f32a-0651-4e55-ac51-c85a23352a24
Version: 1
Effective Time: 20231006
 
Preferred Pharmaceuticals Inc.