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NDC 71335-1607-00 Meclizine HCL 25 mg 25 mg/1 Details

Meclizine HCL 25 mg 25 mg/1

Meclizine HCL 25 mg is a ORAL TABLET 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: 71335-1607-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71335-1607
Product ID	71335-1607_d1c58a74-5455-4a07-bcb6-cc114032ed12
Associated GPIs
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 HCL 25 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
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	2023-12-31

Package

Package Images

NDC 71335-1607-00 (71335160700)

Pricing Information	N/A
NDC Package Code	71335-1607-0
Billing NDC	71335160700
Package	120 TABLET in 1 BOTTLE (71335-1607-0)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d1c58a74-5455-4a07-bcb6-cc114032ed12 Details

Drug Facts

Active ingredient (in each tablet)

Meclizine HCL 25 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness
for others uses, consult your doctor

Warnings

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 if you are taking sedatives or tranquilizers

When using this prodcut

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

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

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other information

Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
store at room temperature 15°-30°C (59°-86°F)
This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

HOW SUPPLIED

NDC: 71335-1607-1: 30 Tablets in a BOTTLE

NDC: 71335-1607-2: 20 Tablets in a BOTTLE

NDC: 71335-1607-3: 25 Tablets in a BOTTLE

NDC: 71335-1607-4: 40 Tablets in a BOTTLE

NDC: 71335-1607-5: 60 Tablets in a BOTTLE

NDC: 71335-1607-6: 90 Tablets in a BOTTLE

NDC: 71335-1607-7: 8 Tablets in a BOTTLE

NDC: 71335-1607-8: 14 Tablets in a BOTTLE

NDC: 71335-1607-9: 10 Tablets in a BOTTLE

NDC: 71335-1607-0: 120 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Meclizine 25MG Chewable

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG

meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1607(NDC:69618-028)
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	pink (Light Raspberry color)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1607-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
2	NDC:71335-1607-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2020
3	NDC:71335-1607-3	25 in 1 BOTTLE; Type 0: Not a Combination Product	09/10/2021
4	NDC:71335-1607-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
5	NDC:71335-1607-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2022
6	NDC:71335-1607-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2020
7	NDC:71335-1607-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
8	NDC:71335-1607-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
9	NDC:71335-1607-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	09/09/2021
10	NDC:71335-1607-0	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	11/01/2015

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1607) , RELABEL(71335-1607)

Revised: 2/2022

Document Id: d1c58a74-5455-4a07-bcb6-cc114032ed12

Set id: d1c58a74-5455-4a07-bcb6-cc114032ed12

Version: 3

Effective Time: 20220214

Search by Drug Name or NDC

NDC 71335-1607-00 Meclizine HCL 25 mg 25 mg/1 Details

Meclizine HCL 25 mg 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-1607-00 (71335160700)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d1c58a74-5455-4a07-bcb6-cc114032ed12 Details

Drug Facts

Active ingredient (in each tablet)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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