MECLIZINE- meclizine hcl 12.5 mg tablet

MECLIZINE by

Drug Labeling and Warnings

MECLIZINE by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Meclizine HCl 12.5 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

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

Do not take this product, unless directed by a doctor, if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• do not exceed recommended dosage
• may cause drowsiness
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• use caution 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 (1-800-222-1222).

Directions

• dosage should be taken one hour before travel starts 

• adults and children 12 years and over:

  take 2 or 4 caplets once daily or as directed by a doctor

Other information

• each caplet contains: calcium 28 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

1-800-645-2158

PRINCIPAL DISPLAY PANEL

Rugby®

NDC: 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

INGREDIENTS AND APPEARANCE

MECLIZINE 
meclizine hcl 12.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1297
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (CAPSULE SHAPED TABLET)	Size	13mm
Flavor		Imprint Code	PH049
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1297-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020
2	NDC: 0536-1297-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	05/21/2020

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	analysis(0536-1297) , manufacture(0536-1297) , repack(0536-1297)