Meclizine HCl 25 mg Chewable Tablets

Drug Labeling and Warnings

Drug Details [pdf]

MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable 
Preferred 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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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: 68788-6944-3

Plus Pharma

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 TABLETS25 mg each

Repackaged By: Preferred Pharmaceuticals Inc.

MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-6944(NDC: 51645-994)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-6944-3	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2017	10/25/2019
2	NDC: 68788-6944-5	25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/22/2017	10/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	04/17/2017	10/25/2019

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-6944)

Revised: 10/2019

Document Id: ffdac0ed-d29d-48cf-aab1-5cef06c25e21

34390-5

Set id: 20a410bc-d667-490e-90ec-77d8cc19fee2

Version: 4

Effective Time: 20191025

 

Preferred Pharmaceuticals Inc.