OTC Medication Information: Rugby Travel Sickness Meclizine HCl, 25 Mg Each (ANTIEMETIC)

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hydrochloride 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.

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
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CROSCARMELLOSE SODIUM
DEXTROSE, UNSPECIFIED FORM
FD&C RED NO. 40
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM SULFATE
SUCROSE
TRICALCIUM PHOSPHATE
Product Characteristics
Color pink Score 2 pieces
Shape ROUND (Biconvex Uncoated Tablet with Bisect) Size 8mm
Flavor Imprint Code 21G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-306-10 10 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
2 NDC:63187-306-15 15 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
3 NDC:63187-306-20 20 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
4 NDC:63187-306-30 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 08/19/2014
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-306), RELABEL (63187-306)

Revised: 01/2021 Proficient Rx LP

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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