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 25 mg

Active ingredient (in each tablet)

Meclizine HCL 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

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

• breathing problems, such as emphysema or chronic bronchitis

• difficulty 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

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• 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 a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Other information

Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

Questions or Comments?

Call 1-855-642-2594

Tamper evident:Do not use if safety seal is broken or missing

Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY*

*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ®

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Rev.:10/2022

NDC 24689-146-01

Meclizine HCL 25 mg

Antiemetic

100 Tablets

Meclizine HCl 25 mg YELLOW _label

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-146
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize9mm
FlavorImprint Code AM4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-146-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00911/21/2022
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917manufacture(24689-146) , analysis(24689-146) , pack(24689-146)

Revised: 11/2022
Document Id: ed43bf21-f3db-245c-e053-2995a90a504c
Set id: ed43bf21-f3da-245c-e053-2995a90a504c
Version: 1
Effective Time: 20221112
 
APNAR PHARMA LP