MECLIZINE- meclizine hydrochloride tablet, chewable

Meclizine by

Drug Labeling and Warnings

Meclizine by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC, Pharbest Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Meclizine HCl 25 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 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 aretaking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• do not exceed recommended dosage
• drowsiness may occures
• 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 (1-800-222-1222)

Directions

• doage should be taken 1 hour before travel starts  

• adults and children 12 years and over:

  take 1 or 2 tablets 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Inactive ingredients

croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid.

Questions or comments?

call 1-800-630-8895, 8:30 am - 4.30 pm ET, Monday-Friday

PRINCIPAL DISPLAY PANEL

NDC: 80513-421-02

*Compare to the active ingredient in Bonine ®

Meclizine HCl 25 mg

Raspberry Flavor

Antiemetic

Motion Sickness 

Vomiting

Nausea

200 CHEWABLE TABLETS

*This product is not manufactured or distributed by WellSpring Pharmaceuticals Corporation., owner of the registered trademark Bonine ®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach, FL 33162 U.S.A.

Manufactured in the USA

INGREDIENTS AND APPEARANCE

MECLIZINE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-421
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
RASPBERRY (UNII: 4N14V5R27W)

Product Characteristics
Color	pink (LIGHT PINK COLOR)	Score	2 pieces
Shape	ROUND (ROUND TABLET)	Size	8mm
Flavor		Imprint Code	PH051
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-421-02	200 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	12/01/2024

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(80513-421) , pack(80513-421) , analysis(80513-421) , label(80513-421)