RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable 
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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TRAVEL SICKNESS CHEWABLE TABLETS

Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 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 it 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

Other information

Inactive ingredients

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

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

Rugby®

NDC 0536-1018-01

Travel Sickness

Meclizine HCl, USP 25 mg Each

(ANTIEMETIC)

100 CHEWABLE TABLETS

Rugby Meclizine 1018

RUGBY TRAVEL SICKNESS  MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1018
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
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
SUCROSE (UNII: C151H8M554)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Product Characteristics
ColorpinkScore2 pieces
ShapeROUND (Biconvex Uncoated Tablet with Bisect) Size8mm
FlavorImprint Code 21G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1018-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/201409/30/2022
2NDC:0536-1018-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/201409/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/19/201409/30/2022
Labeler - RUGBY LABORATORIES (079246066)
Registrant - GEMINI PHARMACEUTICALS INC. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
GEMINI PHARMACEUTICALS INC.055942270manufacture(0536-1018)

Revised: 11/2020
Document Id: b3db2774-223a-cfdf-e053-2995a90aa68c
Set id: bfc7c2c0-d446-4495-a2b2-e609ad581c52
Version: 4
Effective Time: 20201111
 
RUGBY LABORATORIES