MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable MECLIZINE HCL- meclizine hcl 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:
DIRECTRX
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiemetic Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
Authorization status:
OTC monograph final
Authorization number:
61919-454-30, 61919-641-20

MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable

MECLIZINE HCL- meclizine hcl tablet, chewable

DIRECTRX

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.

----------

MECLIZINE HYDROCHLORIDE

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

Antiemetic

Uses prevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

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

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.

When using this product

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 the poison control

center immediately.

Directions

Dosage should be taken one hour before travel starts

Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a

doctor

Other information

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet

Store at room temperature in a dry place

Keep lid tightly closed

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin,

microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar,

tricalcium phosphate.

Questions or comments?

call 1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR

MISSING

In case of overdose, get medical help or contact a Poison Control Center right away.

MECLIZINE HYDROCHLORIDE

meclizine hydrochloride tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -454(NDC:0 536 -10 18 )

Route of Administration

ORAL

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

ASPARTAME (UNII: Z0 H242BBR1)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SUCRO SE (UNII: C151H8 M554)

DEXTRO SE (UNII: IY9 XDZ35W2)

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

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

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

TRICALCIUM PHO SPHATE (UNII: K4C0 8 XP6 6 6 )

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM SULFATE (UNII: 0 YPR6 5R21J)

Product Characteristics

Color

pink

S core

2 pieces

S hap e

ROUND (Bico nvex Unco ated Tablet with Bisect)

S iz e

8 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -454-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/10 /20 19

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 4/10 /20 19

MECLIZINE HCL

meclizine hcl tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 19 19 -6 41(NDC:49 48 3-333)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MECLIZINE HYDRO CHLO RIDE (UNII: HDP7W44CIO) (MECLIZINE -

UNII:3L5TQ 8 4570 )

MECLIZINE

HYDROCHLORIDE

25 mg in 25

DIRECTRX

Inactive Ingredients

Ingredient Name

Stre ng th

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

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

DEXTRO SE (UNII: IY9 XDZ35W2)

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

RASPBERRY (UNII: 4N14V5R27W)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

MO DIFIED CO RN STARCH ( 1-O CTENYL SUCCINIC ANHYDRIDE) (UNII: 46 1P5CJN6 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

VANILLA (UNII: Q74T350 78 H)

Product Characteristics

Color

pink

S core

2 pieces

S hap e

ROUND

S iz e

9 mm

Flavor

RASPBERRY

Imprint Code

TCL333

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -6 41-20

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/10 /20 19

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 4/10 /20 19

Labeler -

DIRECT RX (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

DIRECTRX

0 79 254320

repack(6 19 19 -454, 6 19 19 -6 41)

Revised: 4/2019

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