MECLIZINE by RPK Pharmaceuticals, Inc. Drug Facts

MECLIZINE by

Drug Labeling and Warnings

MECLIZINE by is a Otc medication manufactured, distributed, or labeled by RPK Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MECLIZINE- meclizine hcl 25mg tablet, chewable 
RPK Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

Do not use for children under 12 years of age unless directed by a doctor.

Do not take unless directed by a doctor if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

• do not exceed recommended dosage
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• 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.

Directions

• doage should be taken 1 hour before travel starts  

• Adults and children 12 years and over:

  take 1 or 2 tablets once daily or as directed by doctor

Other information

• Tamper Evident: do not use if safety seal under cap is broken or missing
• store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

HOW SUPPLIED

Product: 53002-7651

NDC: 53002-7651-1 10 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7651-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7651-3 30 TABLET, CHEWABLE in a BOTTLE

MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE

MECLIZINE 
meclizine hcl 25mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53002-7651(NDC: 66424-387)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (LIGHT PINK COLOR)	Score	2 pieces
Shape	ROUND (ROUND TABLET)	Size	8mm
Flavor		Imprint Code	PH051
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53002-7651-1	10 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021	01/01/2022
2	NDC: 53002-7651-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021	01/01/2022
3	NDC: 53002-7651-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	02/01/2018	01/01/2022

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Establishment
Name	Address	ID/FEI	Business Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-7651) , REPACK(53002-7651)

Revised: 11/2023

Document Id: b789fa11-c62d-45a1-b657-5b43b6d5525d

34390-5

Set id: 054dc945-24f9-4369-80d3-e229941de776

Version: 5

Effective Time: 20231129