RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable 
Proficient Rx LP

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 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

Dosage should be taken one hour before travel starts

Adults and children 12 years of age and older:

Chew 1-2 tablets 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

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
store at room temperature

Inactive ingredients

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

Questions or comments?

1-800-645-2158

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

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN BONINE®

Rugby®

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

NDC 63187-306-30

Travel Sickness

Meclizine HCl, USP 25 mg Each

(ANTIEMETIC)

Contains Aspartame

30 CHEWABLE TABLETS

63187-306-30
RUGBY TRAVEL SICKNESS  MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-306(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, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (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:63187-306-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
2NDC:63187-306-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
3NDC:63187-306-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
4NDC:63187-306-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/19/2014
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-306) , RELABEL(63187-306)

Revised: 1/2021
Document Id: 492007d3-4983-4dc6-a186-bcddc1abea4f
Set id: 5c1a89de-6191-4012-8bc2-8bfc42b89cbd
Version: 3
Effective Time: 20210101
 
Proficient Rx LP