SPL v1
SPL
SPL Set ID b0a2a1f7-354e-48bd-9e98-9207bf9f53fd
Route
ORAL
Published
Effective Date 2024-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Dextrose Fd&c Red No. 40 Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Saccharin Sodium Stearic Acid Raspberry

Identifiers & Packaging

Pill Appearance
Imprint: PH051 Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Meclizine HCl 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25 mg

Uses

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

Section 51945-4

NDC 80513-421-02

*Compare to the active ingredient in Bonine ®

Meclizine HCl 25 mg

Raspberry Flavor

Antiemetic

• Motion Sickness 

• Vomiting

• Nausea

200 CHEWABLE TABLETS

*This product is not manufactured or distributed by WellSpring Pharmaceuticals Corporation., owner of the registered trademark Bonine ®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach, FL 33162 U.S.A.

Manufactured in the USA

Warnings

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

Do not take unless directed by a doctor if you have

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

Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.

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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Inactive Ingredients

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

Questions Or Comments?

call 1-800-630-8895, 8:30 am - 4.30 pm ET, Monday-Friday

When Using This Product
  • do not exceed recommended dosage
  • drowsiness may occures
  • 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 (1-800-222-1222)

Active Ingredient (in Each Tablet)

Meclizine HCl 25 mg


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

NDC 80513-421-02

*Compare to the active ingredient in Bonine ®

Meclizine HCl 25 mg

Raspberry Flavor

Antiemetic

• Motion Sickness 

• Vomiting

• Nausea

200 CHEWABLE TABLETS

*This product is not manufactured or distributed by WellSpring Pharmaceuticals Corporation., owner of the registered trademark Bonine ®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach, FL 33162 U.S.A.

Manufactured in the USA

Purpose

Antiemetic

Warnings

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

Do not take unless directed by a doctor if you have

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

Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.

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 (Other information)
  • Tamper Evident:do not use if safety seal under cap is broken or missing
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call 1-800-630-8895, 8:30 am - 4.30 pm ET, Monday-Friday

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • drowsiness may occures
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)