MECLIZINE- meclizine hcl 25mg tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Available from:
Pharbest Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiemetic prevents and treats nausea, vomiting or dizziness associated with motion sickness
Authorization status:
OTC monograph final
Authorization number:
16103-387-08, 16103-387-11

MECLIZINE- meclizine hcl 25mg tablet, chewable

Pharbest Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25mg

Purpos e

Antiemetic

Us es

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 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 room temperature 20°-25°C (68°-77°F)

Inactive ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline

cellulose, silicon dioxide, sodium saccharine, stearic acid

Ques tions ?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

PHARBEST

NDC 16103-0387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

MECLIZINE

CHEWABLE

Raspberry Flavor

*Compare to the active ingredient in Bonine

Meclizine HCl 25mg

Anti-Emetic

Motion Sickness Nausea Vomiting

1000 TABLETS

MECLIZINE

meclizine hcl 25mg tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:16 10 3-38 7

Route of Administration

ORAL

Pharbest Pharmaceuticals, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MECLIZINE HYDRO CHLO RIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ8 4570 )

MECLIZINE HYDROCHLORIDE 25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

DEXTRO SE (UNII: IY9 XDZ35W2)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

pink (LIGHT PINK COLOR)

S core

2 pieces

S hap e

ROUND (ROUND TABLET)

S iz e

8 mm

Flavor

Imprint Code

PH0 51

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:16 10 3-38 7-

10 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 18

2

NDC:16 10 3-38 7-

10 0 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/0 1/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt336

0 2/0 1/20 18

Labeler -

Pharbest Pharmaceuticals, Inc. (557054835)

Registrant -

Pharbest Pharmaceuticals, Inc. (557054835)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharbest Pharmaceuticals, Inc.

5570 548 35

manufacture(16 10 3-38 7) , pack(16 10 3-38 7) , analysis(16 10 3-38 7)

Revised: 2/2018

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