MECLIZINE HCL 25 MG- meclizine hcl tablet

Meclizine HCL 25 mg by

Drug Labeling and Warnings

Meclizine HCL 25 mg by is a Otc medication manufactured, distributed, or labeled by Denton Pharma, Inc. DBA Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Meclizine HCL 25 mg

Purpose

Antiemetic

Uses

• prevents and treats nausea, vomiting or dizziness due to motion sickness
• for others uses, consult your doctor

Warnings

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 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

• take dose one hour before travel starts
• tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other information

• Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
• store at room temperature 15°-30°C (59°-86°F)
• This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

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

www.reliable1labs.com

Principal Display Panel

NDC: 70934-197-30

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG 
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70934-197(NDC:69618-028)
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
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	pink (Light Raspberry color)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70934-197-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	12/05/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals		080355546	repack(70934-197)