MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable
Rising 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 Hydrochloride Chewable Tablets 25 mg

Drug Facts
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.

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 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 0.0025 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

Inactive ingredients

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions or comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.
Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine®

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.),
Mumbai 400 030, India

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Mfg. Lic. No.: G/1430
Feb 2022

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

meclizine-100ct

meclizine-1000ct

MECLIZINE HCL
meclizine hydrochloride chewable tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-824
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	pink (Pink to light pink)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	M
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:16571-824-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2022
2	NDC:16571-824-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/18/2022

Labeler - Rising Pharmaceuticals, Inc. (835513529)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		650434645	manufacture(16571-824)

Revised: 8/2022

Document Id: 448cc004-c7a5-42b0-9a2e-79790e66baa8

Set id: 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc

Version: 1

Effective Time: 20220818

Rising Pharmaceuticals, Inc.