MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Rising Pharmaceuticals, Inc., Unique Pharmaceutical Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR/PHARMACIST

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

PREGNANCY OR BREAST FEEDING

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/1430Feb 2022

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hydrochloride chewable tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16571-824
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)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	08/18/2022

Labeler - Rising Pharmaceuticals, Inc. (835513529)

Registrant - Unique Pharmaceutical Laboratories (917165052)

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