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
Aphena Pharma Solutions — Tennessee, LLC

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.

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 in a dry place
  • Keep lid tightly closed

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

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:

Count25 mg
3071610-245-30
9071610-245-60

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:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20190314JH

PRINCIPAL DISPLAY PANEL — 25 mg

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

Bottle Label 25 mg
(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:71610-245(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
FD&C RED NO. 40
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
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:71610-245-30 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
2 NDC:71610-245-60 90 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 — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-245)

Revised: 03/2019 Aphena Pharma Solutions — Tennessee, LLC

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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