Meclizine Hcl 12.5 Mg Tablet [Reliable 1 Laboratories Llc] -

MECLIZINE HCL 12.5 MG TABLET [RELIABLE 1 LABORATORIES LLC]
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NDC	69618-027-01, 69618-027-10
Set ID	32832b0f-0b38-27ce-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Reliable 1 Laboratories LLC
Generic Name
Product Class	Antiemetic
Product Number
Application Number	PART336

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Drug Facts
Active indredient (in each caplet)

Meclizine HCL 12.5 mg
Purpose

Antiemetic
Uses
- prevents and treats nausea, vomiting, or dizziness due to motion sickness
- for other uses, consult your doctor
Warnings
Ask a docotor 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 if you are taking sedatives or tranquilizers

When using this product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquillizers may increase drowsiness
- be careful 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 a Poison Control Center right away.
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 prodcut
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranqulizers may increase drowsiness
- be careful 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 a Poison Control Center right away.
Directions
- adults & children 12 years and over: 2-4 caplets once daily
- children under 12 years: ask a doctor
Other information
- each caplet contains: calcium 51 mg
- store at room temperature 15º-30ºC (59º-86ºF)
- This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
SPL UNCLASSIFIED SECTION

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

Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

www.reliable1labs.com
PRINCIPAL DISPLAY PANEL

NDC 69618-027-10

Meclizine HCL 12.5 mg

ANTIEMETIC

1000 CAPLETS

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 12.5 MG
meclizine hcl 12.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69618-027
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	AP;117
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69618-027-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015
2	NDC:69618-027-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015