MECLIZINE HCl, USP 12.5 mg CAPLETS

Rugby by

Drug Labeling and Warnings

Rugby by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, GEMINI PHARMACEUTICALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl 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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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 the 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, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

Questions or comments?

call 1-800-645-2158

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: 0536-1017-01

Meclizine HCl, USP

12.5 mg Each

ANTIEMETIC

100 CAPLETS

Rugby Meclizine 1017

RUGBY  MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1017
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, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (modified capsule shaped uncoated tablet with bisect) Size3mm
FlavorImprint Code 19G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-1017-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/201401/31/2020
2NDC: 0536-1017-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/201401/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33603/07/201401/31/2020
Labeler - RUGBY LABORATORIES (079246066)
Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
GEMINI PHARMACEUTICALS INC.055942270manufacture(0536-1017)

Revised: 4/2018
 
RUGBY LABORATORIES