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NDC 71335-1215-03 MECLIZINE 25 mg/1 Details

MECLIZINE 25 mg/1

MECLIZINE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is MECLIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Related Packages: 71335-1215-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71335-1215
Product ID	71335-1215_dc78e0fc-fccc-45a2-a33b-2a2eeb5caab9
Associated GPIs	50200050000510
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MECLIZINE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCl 25mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71335-1215-03 (71335121503)

Pricing Information	N/A
NDC Package Code	71335-1215-3
Billing NDC	71335121503
Package	25 TABLET, CHEWABLE in 1 BOTTLE (71335-1215-3)
Marketing Start Date	2019-05-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 623db9de-4224-47ce-84b7-6eaefe97290e Details

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 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

Questions?

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

HOW SUPPLIED

Product: 71335-1215

NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE

Meclizine 25MG Chewable

INGREDIENTS AND APPEARANCE

MECLIZINE

meclizine hcl 25mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1215(NDC:66424-387)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1215-0	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
2	NDC:71335-1215-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
3	NDC:71335-1215-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
4	NDC:71335-1215-3	25 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
5	NDC:71335-1215-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
6	NDC:71335-1215-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
7	NDC:71335-1215-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
8	NDC:71335-1215-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
9	NDC:71335-1215-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
10	NDC:71335-1215-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019

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

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1215) , RELABEL(71335-1215)

Revised: 6/2019

Document Id: dc78e0fc-fccc-45a2-a33b-2a2eeb5caab9

Set id: 623db9de-4224-47ce-84b7-6eaefe97290e

Version: 1

Effective Time: 20190613