MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable
Proficient Rx LP

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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Meclizine HCl 25 mg Chewable Tablets

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Purpose

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 if you are taking sedatives or tranquilizers.

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

•: store at room temperature

•: Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
•: Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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?

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

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

NDC 63187-755-30

Plus Pharma

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Meclizine HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

Prevents nausea, dizziness and vomiting

*Compare to the Active Ingredient in Bonine®

Raspberry

30 CHEWABLE TABLETS

25 mg each

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

CHEWABLE TABLETS

25 mg each

MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-755(NDC:51645-994)
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
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	pink (Uncoated)	Score	2 pieces
Shape	ROUND (Biconvex)	Size	8mm
Flavor	RASPBERRY	Imprint Code	21G
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-755-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2016	12/31/2021
2	NDC:63187-755-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2016	12/31/2021
3	NDC:63187-755-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2016	12/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	10/15/2015	12/31/2021

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-755)

Revised: 10/2022

Document Id: 9b192c7f-d7d8-4e0c-a78d-b14742f3fc48

Set id: e3499822-3e3f-43a3-b48d-4436f6cad8a3

Version: 4

Effective Time: 20221001

Proficient Rx LP