MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable 
BluePoint Laboratories

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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

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

label count 100label 1000

MECLIZINE HCL 
meclizine hydrochloride chewable tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-529
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
SUCROSE (UNII: C151H8M554)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DEXTROSE (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
RASPBERRY (UNII: 4N14V5R27W)  
Product Characteristics
Colorpink (Pink to light pink) Score2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68001-529-00100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2022
2NDC:68001-529-081000 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00903/14/2022
Labeler - BluePoint Laboratories (985523874)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(68001-529)

Revised: 2/2024
Document Id: 11d28658-55a1-ff25-e063-6394a90a7e65
Set id: d9cc2705-9dcc-0a73-e053-2995a90aafe6
Version: 2
Effective Time: 20240221
 
BluePoint Laboratories