MECLIZINE- meclizine hcl 12.5 mg tablet

MECLIZINE by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each caplet)

Meclizine HCl 12.5mg

Purpose

Antiemetic

Uses

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

Warnings

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

Do not take unless directed by a doctor if you have

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

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

When using this product

• do not exceed recommended dosage
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• 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

• doage should be taken 1 hour before travel starts 

• Adults and children 12 years and over:

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

Other information

• Tamper Evident: do not use if safety seal under cap is broken or missing
• store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

PRINCIPAL DISPLAY PANEL

NDC: 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

Motion Sickness  Nausea  Vomiting

1000 CAPLETS

SDA

LABORATORIES

INGREDIENTS AND APPEARANCE

MECLIZINE 
meclizine hcl 12.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66424-386
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 (WHITE COLOR)	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: 66424-386-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018
2	NDC: 66424-386-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	02/01/2018

Labeler - SDA Laboratories, Inc. (948067889)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(66424-386) , pack(66424-386) , analysis(66424-386)