MECLIZINE HCL 12.5 MG- meclizine hcl 12.5 mg tablet
Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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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Meclizine HCL 12.5mg

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 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 if you are taking sedatives or tranquilizers

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

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.

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

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

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

www.reliable1labs.com

Principal Display Panel

NDC: 70934-196-30

Label

MECLIZINE HCL 12.5 MG
meclizine hcl 12.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70934-196(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	Marketing End Date
Packaging
1	NDC:70934-196-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2019	07/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	07/10/2019	07/31/2020

Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)

Name	Address	ID/FEI	Business Operations
Establishment
Denton Pharma, Inc. DBA Northwind Pharmaceuticals		080355546	repack(70934-196)

Revised: 7/2021

Document Id: c826626c-3528-b6c9-e053-2995a90a8ad7

Set id: 958275dd-9874-3295-e053-2a95a90ac539

Version: 3

Effective Time: 20210727

Denton Pharma, Inc. DBA Northwind Pharmaceuticals