RUGBYMECLIZINE HCL, 12.5 MG EACH ANTIEMETIC MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
REMEDYREPACK INC.

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.

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Drug Facts

OTC - ACTIVE INGREDIENT

Meclizine HCl USP 12.5 mg

OTC - PURPOSE

Antiemetic

INDICATIONS & USAGE

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

WARNINGS

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 if you are taking sedatives or tranquilizers.

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.

In case of overdose, get medical help or contact the poison control center immediately.

DOSAGE & ADMINISTRATION

Dosage should be taken one hour before travel starts.

Adults and children 12 years of age and older:

take 2-4 caplets 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

SPL UNCLASSIFIED

store at room temperature

Each Caplet Contains: Calcium 25 mg
Each Caplet Contains: Sodium 5mg

INACTIVE INGREDIENT

croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

OTC - QUESTIONS

1-800-645-2158

OTHER SAFETY INFORMATION

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

OTC - KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: RugbyMeclizine HCl, 12.5 mg Each ANTIEMETIC Meclizine HCl, 12.5 mg Each ANTIEMETIC

GENERIC: Meclizine HCl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-099-02

ACTIVE INGREDIENT(S):

MECLIZINE HYDROCHLORIDE 12.5mg in 1

INACTIVE INGREDIENT(S):

CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM SULFATE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
STEARIC ACID

COLOR: white

SHAPE: CAPSULE

SCORE: Two even pieces

SIZE: 3 mm

IMPRINT: 19G

PACKAGING: 30 in 1 BLISTER PACK

MM1

MM2

RUGBYMECLIZINE HCL, 12.5 MG EACH ANTIEMETIC MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-099(NDC:0536-1017)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE (TABLET)	Size	3mm
Flavor		Imprint Code	19G
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-099-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	11/21/2014	12/30/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	11/21/2014	12/30/2016

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2017

Document Id: 494fc379-9dc9-0d5d-e054-00144ff8d46c

Set id: aaceaf7a-b586-483b-958a-73e0a2e5b567

Version: 2

Effective Time: 20170224

REMEDYREPACK INC.