MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable 
Bryant Ranch Prepack

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

HOW SUPPLIED

NDC: 71335-9751-1: 30 Tablets in a BOTTLE

NDC: 71335-9751-2: 20 Tablets in a BOTTLE

NDC: 71335-9751-3: 25 Tablets in a BOTTLE

NDC: 71335-9751-4: 40 Tablets in a BOTTLE

NDC: 71335-9751-5: 60 Tablets in a BOTTLE

NDC: 71335-9751-6: 90 Tablets in a BOTTLE

NDC: 71335-9751-7: 8 Tablets in a BOTTLE

NDC: 71335-9751-8: 14 Tablets in a BOTTLE

NDC: 71335-9751-9: 10 Tablets in a BOTTLE

NDC: 71335-9751-0: 120 Tablets in a BOTTLE

Meclizine 25 mg Chewable

Label
MECLIZINE HCL 
meclizine hydrochloride chewable tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9751(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:71335-9751-130 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
2NDC:71335-9751-220 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
3NDC:71335-9751-325 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
4NDC:71335-9751-440 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
5NDC:71335-9751-560 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
6NDC:71335-9751-690 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
7NDC:71335-9751-78 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
8NDC:71335-9751-814 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
9NDC:71335-9751-910 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
10NDC:71335-9751-0120 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/18/2022
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-9751) , RELABEL(71335-9751)

Revised: 7/2023
Document Id: 364998f2-bf0b-4a82-9afb-1f2a3ac604d3
Set id: 12446adb-0ff6-4f92-8bb2-b64b11d47e76
Version: 100
Effective Time: 20230719
 
Bryant Ranch Prepack