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

Rugby Travel Sickness by

Drug Labeling and Warnings

Rugby Travel Sickness by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

PURPOSE

Purpose

Antiemetic

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

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

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 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	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-245)