Rugby Travel Sickness Meclizine Hcl, 25 Mg Each (Antiemetic) (Meclizine Hcl) Tablet, Chewable [Rugby Laboratories] -

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [RUGBY LABORATORIES]
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NDC	0536-1018-01, 0536-1018-10
Set ID	bfc7c2c0-d446-4495-a2b2-e609ad581c52
Category	HUMAN OTC DRUG LABEL
Packager	RUGBY LABORATORIES
Generic Name
Product Class	Antiemetic
Product Number
Application Number	PART336

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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

Rugby®

NDC 0536-1018-01

Travel Sickness

Meclizine HCl, USP 25 mg Each

(ANTIEMETIC)

100 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: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 (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1018-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2014	09/30/2022
2	NDC:0536-1018-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/19/2014	09/30/2022