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 REMEDYREPACK INC.. 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

PRINCIPAL DISPLAY PANEL

DRUG: Rugby Travel SicknessMeclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl, 25 mg Each (Antiemetic)

GENERIC: Meclizine HCl

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-0361-0

COLOR: pink

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: 21G

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• MECLIZINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

• ASPARTAME
• SILICON DIOXIDE
• CELLULOSE, MICROCRYSTALLINE
• SODIUM SULFATE
• SUCROSE
• MALTODEXTRIN
• CROSCARMELLOSE SODIUM
• DEXTROSE
• MAGNESIUM STEARATE
• FD&C RED NO. 40
• TRICALCIUM PHOSPHATE

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: 70518-0361(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: 70518-0361-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	03/24/2017

Labeler - REMEDYREPACK INC. (829572556)