MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable

Meclizine HCl 25 mg by

Drug Labeling and Warnings

Meclizine HCl 25 mg by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc. dba Plus Pharma, Gemini Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

Do not use in children under 12 years of age unless directed by a doctor.

ASK 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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

WHEN USING

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

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

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? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

PRINCIPAL DISPLAY PANEL

NDC: 51645-994-01

Plus Pharma®

MECLIZINE HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

*Compare to the Active Ingredient in Bonine®

Prevents nausea, dizziness and vomiting

Raspberry

100 CHEWABLE TABLETS 25 mg each

PRINCIPAL DISPLAY PANEL

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Plus Pharma®

NDC: 51645-994-10

MECLIZINE HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

Prevents nausea, dizziness and vomiting

*Compare to the Active Ingredient in Bonine®

Raspberry Natural & Artificial Flavor

Contains no ingredient from a gluten-containing grain (wheat, barley, or rye).

1000 CHEWABLE TABLETS 25 mg each

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51645-994
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)
SUCROSE (UNII: C151H8M554)
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)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	pink (Uncoated)	Score	2 pieces
Shape	ROUND (Biconvex)	Size	8mm
Flavor	RASPBERRY	Imprint Code	21G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51645-994-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2015
2	NDC: 51645-994-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	10/15/2015

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture(51645-994)