MECLIZINE HCL 12.5 MG tablet

Meclizine HCL 12.5 mg by

Drug Labeling and Warnings

Meclizine HCL 12.5 mg by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (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 tranquilizers 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 product

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers 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 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 71205-762-90

Meclizine HCL 12.5 mg

ANTIEMETIC

90 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: 71205-762(NDC:69618-027)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-762-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2023
2	NDC: 71205-762-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2023
3	NDC: 71205-762-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	11/01/2015

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(71205-762) , RELABEL(71205-762)