MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable 
Rising 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 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

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

When using this product

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

Other Information

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

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

meclizine-100ct

meclizine-1000ct

MECLIZINE HCL 
meclizine hydrochloride chewable tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (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:16571-824-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2022
2NDC:16571-824-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/18/2022
Labeler - Rising Pharmaceuticals, Inc. (835513529)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(16571-824)

Revised: 8/2022
Document Id: 448cc004-c7a5-42b0-9a2e-79790e66baa8
Set id: 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc
Version: 1
Effective Time: 20220818
 
Rising Pharmaceuticals, Inc.