MECLIZINE- meclizine hcl 25mg tablet, chewable

Meclizine by

Drug Labeling and Warnings

Meclizine by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC, PHARBEST PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Meclizine HCl 25mg

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 the 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 1 or 2 tablets once daily or as directed by doctor

Other information

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

Inactive ingredients

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

Questions or comments?

(866) 562-2756 (Mon - Fri, 8AM - 4PM EST)

Package Label Principal Display Panel

PHARMAMED

NDC: 84289-387-01

Manufactured in the USA

Chewable, Once-A-Day Protection

MECLIZINE

Antiemetic

100 CHEWABLE TABLETS

Meclizine HCL 25mg

Raspberry Flavor

*Compare to the active ingredient in Bonine

INGREDIENTS AND APPEARANCE

MECLIZINE 
meclizine hcl 25mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-387(NDC:16103-387)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DEXTROSE (UNII: IY9XDZ35W2)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
RASPBERRY (UNII: 4N14V5R27W)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	PH051
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-387-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2024

Labeler - PHARMAMED USA INC (065607328)

Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
PHARBEST PHARMACEUTICALS, INC.		557054835	repack(84289-387)