RUGBY MECLIZINE HCL- meclizine hydrochloride tablet, film coated 
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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MECLIZINE HCl, USP 12.5 mg CAPLETS

Drug Facts

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble 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

  • ​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.

Directions

  • Dosage should be taken one hour before travel starts
  • Adults and children 12 years of age and older: take 2-4 caplets once daily, or as directed by a doctor
  • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

Other information

  • Each Caplet Contains: Calcium 25 mg
  • Store at room temperature in a dry place
  • Keep lid tightly closed

Inactive ingredients

croscarmellose sodium, dicalcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, titanium dioxide.

Questions or comments?

Call1-800-645-2158

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

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rugby®

NDC 0536-1178-01

NEW FORMULA AND APPEARANCE

Meclizine HCl, USP

12.5 mg Each

ANTIEMETIC

100 CAPLETS

0536-1178 100-ct

RUGBY MECLIZINE HCL 
meclizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1178
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (Film Coated) Score2 pieces
ShapeCAPSULE (Modified) Size13mm
FlavorImprint Code 19G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1178-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/201807/31/2022
2NDC:0536-1178-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/201807/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33604/20/201807/31/2022
Labeler - RUGBY LABORATORIES (079246066)

Revised: 11/2020
Document Id: b3db13b7-cd9f-1e60-e053-2995a90acb36
Set id: 6a48ec0c-773d-7f97-e053-2991aa0a0351
Version: 5
Effective Time: 20201111
 
RUGBY LABORATORIES