MECLIZINE HCL- meclizine hydrochloride tablet 
Rising Pharma Holdings, 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 Tablets

Drug Facts
Active ingredient (in each tablet)

12.5 mg Tablet: Meclizine HCl    12.5 mg

25 mg Tablet: Meclizine HCl     25 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Directions

  • dosage should be taken one hour before travel starts

for 25 mg: adults and children 12 years and over, take 1 or 2 tablets once daily or directed by a doctor

for 12.5 mg: adults and children 12 years and over, take 2 or 4 tablets once daily or directed by a doctor

Inactive Ingredients 

magnesium sterate, 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].

Questions or Comments?

Call 1-844-474-7464

Warnings

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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 immediately (1-800-222-1222).

Manufactured by:

Aurex laboratories LLC
East Windsor, NJ 08520

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Revised:08/2021

Meclizine HCl Tablets

25 mg

100

meclizine-25mg-front

meclizine-25mg-back

Meclizine HCl Tablets

12.5 mg

100

meclizine-12.5mg

meclizine-12.5mg-back

MECLIZINE HCL 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-751
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorwhite (White to off white) Score2 pieces
ShapeROUNDSize8mm
FlavorImprint Code A;C4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-751-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/17/202101/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/17/202101/31/2023
MECLIZINE HCL 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-752
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code AM7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-752-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/17/202102/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/17/202102/28/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)
Registrant - Aurex Laboratories Limited Liability Company (067585317)
Establishment
NameAddressID/FEIBusiness Operations
Aurex Laboratories Limited Liability Company067585317manufacture(16571-751, 16571-752) , pack(16571-751, 16571-752) , analysis(16571-751, 16571-752) , label(16571-751, 16571-752)

Revised: 7/2023
 
Rising Pharma Holdings, Inc.