FDA.reportPublic FDA data

Meclizine Hydrochloride Chewable Tablets 25 mg

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-06-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-16 05:10:08

Label at a glance#

ProductMeclizine HCl
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness due to motion sickness.

Dosage and administration

• 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

Storage and handling

• Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet • Store at room temperature in a dry place • Keep lid tightly closed

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl, USP 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness due to motion sickness.

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact the Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
  • Store at room temperature in a dry place
  • Keep lid tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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 Laborat...

SPL UNCLASSIFIED SECTION

Repackaged By: Preferred Pharmaceutical Inc.

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine Hydrochloride Chewable Tablets

25 mg

68788-8529

Meclizine HCL 25mg Chewable Tablets
Meclizine HCL 25mg Chewable Tablets

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128118A7F3F32A-0651-4E55-AC51-C85A23352A24-00.jpg
Data codeData Matrix**080525*A7F3F32A-0651-4E55-AC51-C85A23352A24-00.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8529-1EA - Each68788-8529674def47-e92a-4646-92fe-c15cc388774612023-12-05
68788-8529-3EA - Each68788-8529b3740cbc-0707-45be-b3a4-aebeb454186712023-12-05
16571-824-01EA - Each16571-82422e61447-4473-4367-ad19-2356f9186e4112022-11-07
16571-824-10EA - Each16571-824c3998c46-db63-4938-a29e-2998bfb410ec12022-11-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-852968788-8529-1, 68788-8529-3
16571-824

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
RASPBERRY4N14V5R27WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM SULFATE ANHYDROUS36KCS0R750IACT
SUCROSEC151H8M554IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-08-05full-release2026-06-01 01:09:23

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEPreferred Pharmaceuticals Inc.a7f3f32a-0651-4e55-ac51-c85a23352a242026-06-12WarningsExact identifier
ndc (package): 68788-8529-3
ndc (package): 68788-8529-1
ndc (product): 68788-8529
ndc11 (package): 68788852903
ndc11 (package): 68788852901
spl id: a2db9af5-9e32-4296-9688-b92e560e67cf
spl set id: a7f3f32a-0651-4e55-ac51-c85a23352a24
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLERising Pharma Holdings, Inc.6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc2024-11-08WarningsExact identifier
ndc (product): 16571-824

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.