Quality Choice 44-404 Delisted

Quality Choice 44-404 Delisted
SPL v12
SPL
SPL Set ID 6872c83f-905d-40e6-a451-1d080dd5314c
Route
ORAL
Published
Effective Date 2024-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Starch, Corn Fd&c Red No. 40 Anhydrous Lactose Magnesium Stearate Saccharin Sodium Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;404 Shape: round Color: pink Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2002-05-29 Until 2026-04-18

Description

Meclizine HCl 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25 mg

Uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Directions
  • dosage should be taken one hour before travel starts
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
Do Not Use

for children under 12 years of age unless directed by a doctor.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from heat and humidity
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 63868-163-16

QC

QUALITY

CHOICE®

*Compare to the

Active Ingredient in

BONINE® Chewable Tablets

Travel Ease

Meclizine HCI 25 mg Chewable Tablets | Antiemetic

Motion Sickness Relief

Prevents Motion Sickness

Up To 24 Hours of Protection

Chew or crush tablets

completely before swallowing.

Raspberry Flavored

16 Tablets (25 mg Each)

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Insight Pharmaceuticals LLC,

owner of the registered trademark Bonine®

Chewable Tablets.

50844        REV1218A40421

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

100%

QC

Satisfaction

Guaranteed

Quality Choice 44-404

When Using This Product
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic beverages
  • 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 a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient (in Each Chewable Tablet)

Meclizine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Purpose

Antiemetic

Directions
  • dosage should be taken one hour before travel starts
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
Do Not Use (Do not use)

for children under 12 years of age unless directed by a doctor.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from heat and humidity
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 63868-163-16

QC

QUALITY

CHOICE®

*Compare to the

Active Ingredient in

BONINE® Chewable Tablets

Travel Ease

Meclizine HCI 25 mg Chewable Tablets | Antiemetic

Motion Sickness Relief

Prevents Motion Sickness

Up To 24 Hours of Protection

Chew or crush tablets

completely before swallowing.

Raspberry Flavored

16 Tablets (25 mg Each)

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF

BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or

distributed by Insight Pharmaceuticals LLC,

owner of the registered trademark Bonine®

Chewable Tablets.

50844        REV1218A40421

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

100%

QC

Satisfaction

Guaranteed

Quality Choice 44-404

When Using This Product (When using this product)
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic beverages
  • use caution 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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Meclizine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)