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NDC 71610-0245-60 Rugby Travel Sickness 25 mg/1 Details

Rugby Travel Sickness 25 mg/1

Rugby Travel Sickness is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is MECLIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Related Packages: 71610-0245-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71610-0245
Product ID	71610-245_4c668824-7502-4799-8efc-e93581cd75d0
Associated GPIs	50200050000510
GCN Sequence Number	004736
GCN Sequence Number Description	meclizine HCl TAB CHEW 25 MG ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	18312
HICL Sequence Number	001975
HICL Sequence Number Description	MECLIZINE HCL
Brand/Generic	Generic
Proprietary Name	Rugby Travel Sickness
Proprietary Name Suffix	Meclizine HCl, 25 mg Each (Antiemetic)
Non-Proprietary Name	Meclizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0245-60 (71610024560)

Pricing Information	N/A
NDC Package Code	71610-245-60
Billing NDC	71610024560
Package	90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71610-245-60)
Marketing Start Date	2019-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 099d75cc-a2c7-4140-9884-b45010aaf2b5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

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Purpose

Antiemetic

SPL UNCLASSIFIED SECTION

Uses prevents and treats nausea, vomiting or dizziness due to motion sickness

SPL UNCLASSIFIED SECTION

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.

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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

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Other information

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

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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.

SPL UNCLASSIFIED SECTION

Questions or comments?

call 1-800-645-2158

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

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Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	25 mg
30	71610-245-30
90	71610-245-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190314JH

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 71610-245 - Meclizine HCl (Travel Sickness) 25 mg Chewable Tablets

INGREDIENTS AND APPEARANCE

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)

meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-245(NDC:0536-1018)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	pink	Score	2 pieces
Shape	ROUND (Biconvex Uncoated Tablet with Bisect)	Size	8mm
Flavor		Imprint Code	21G
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71610-245-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2019
2	NDC:71610-245-60	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/19/2014

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-245)

Revised: 3/2019

Document Id: 4c668824-7502-4799-8efc-e93581cd75d0

Set id: 099d75cc-a2c7-4140-9884-b45010aaf2b5

Version: 1

Effective Time: 20190314

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NDC 71610-0245-60 Rugby Travel Sickness 25 mg/1 Details

Rugby Travel Sickness 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71610-0245-60 (71610024560)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 099d75cc-a2c7-4140-9884-b45010aaf2b5 Details

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Repackaging Information

PRINCIPAL DISPLAY PANEL - 25 mg

INGREDIENTS AND APPEARANCE

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