MECLIZINE- meclizine hcl 12.5 mg tablet 
RUGBY LABORATORIES

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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Drug Facts

Active ingredient (in each caplet)

Meclizine HCl 12.5 mg

Purpose

Antiemetic

Uses

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

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

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 right away (1-800-222-1222).

Directions

adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by a doctor

Other information

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-645-2158

Rugby®

NDC 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

Rugby Meclizine 12.5 mg Caplet 1000 ct. Product Label Image

MECLIZINE 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1297
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size13mm
FlavorImprint Code PH049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1297-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
2NDC:0536-1297-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33605/21/2020
Labeler - RUGBY LABORATORIES (079246066)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835analysis(0536-1297) , manufacture(0536-1297) , pack(0536-1297)

Revised: 12/2022
Document Id: d3b8b142-4601-45c5-bde1-9c302956ddb6
Set id: 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35
Version: 3
Effective Time: 20221220
 
RUGBY LABORATORIES