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NDC 63187-0306-30 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 Proficient Rx LP. 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: 63187-0306-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	63187-0306
Product ID	63187-306_492007d3-4983-4dc6-a186-bcddc1abea4f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Proficient Rx LP
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 63187-0306-30 (63187030630)

Pricing Information	N/A
NDC Package Code	63187-306-30
Billing NDC	63187030630
Package	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (63187-306-30)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5c1a89de-6191-4012-8bc2-8bfc42b89cbd Details

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

SPL UNCLASSIFIED SECTION

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

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:63187-306(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, 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
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:63187-306-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
2	NDC:63187-306-15	15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
3	NDC:63187-306-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
4	NDC:63187-306-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

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

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(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