MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet 
APNAR PHARMA LP

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 Tablets

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

Purpose

Antiemetic

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

Other Information:

store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]

Do not use in children under 12 years of age unless directed by a doctor

Do not take this product, unless directed by a doctor, if you have

Do not take this product if you are taking

Sedatives or tranquilizers, without first consulting your doctor.

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 a Poison Control Center right away (1-800-222-1222)

Questions or Comments?

Call 1-855-642-2594

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

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

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

Meclizine HCl 12.5 mg tablets -100s

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

Meclizine HCl 25 mg _label-100s

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-138
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code A;C4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-138-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00907/29/2022
MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-139
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code AM7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-139-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00907/29/2022
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917manufacture(24689-138, 24689-139) , analysis(24689-138, 24689-139) , pack(24689-138, 24689-139)
Establishment
NameAddressID/FEIBusiness Operations
INVAHEALTH INC116840615label(24689-138, 24689-139) , pack(24689-138, 24689-139)

Revised: 7/2022
Document Id: e4d785a7-a689-3acb-e053-2a95a90a6d2e
Set id: e4d785a7-a688-3acb-e053-2a95a90a6d2e
Version: 1
Effective Time: 20220728
 
APNAR PHARMA LP