Quality Plus 44-403a

Quality Plus 44-403a
SPL v15
SPL
SPL Set ID 8e1889de-fbef-44f1-bbfb-c68a78e6330c
Route
ORAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Lactose Monohydrate Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 44;403 Shape: round Color: yellow Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-06-24

Description

Meclizine HCl 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25 mg

Uses

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

Directions
  • do not take more than directed
  • take first dose ½ to 1 hour before starting activity
  • adults and children 12 years and over: 1 to 2 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat and humidity
  • see end flap for expiration date and lot number
Inactive Ingredients

colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-403-19

*Compare to active ingredient in

Dramamine® Less Drowsy

Motion Sickness

Relief

LESS DROWSY FORMULA

Meclizine HCl 25 mg • Antiemetic

HELPS PREVENT NAUSEA, VOMITING AND

DIZZINESS DUE TO MOTION SICKNESS

FOR UP TO 24 HOURS

Ages 12 Years and Over

Tablets

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 Medtech Products Inc., owner of the registered trademark

Dramamine® All Day Less Drowsy.      50844       ORG042340319

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-403A
When Using This Product
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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.

Active Ingredient (in Each Tablet)

Meclizine HCl 25 mg

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 
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses

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

Purpose

Antiemetic

Directions
  • do not take more than directed
  • take first dose ½ to 1 hour before starting activity
  • adults and children 12 years and over: 1 to 2 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat and humidity
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-403-19

*Compare to active ingredient in

Dramamine® Less Drowsy

Motion Sickness

Relief

LESS DROWSY FORMULA

Meclizine HCl 25 mg • Antiemetic

HELPS PREVENT NAUSEA, VOMITING AND

DIZZINESS DUE TO MOTION SICKNESS

FOR UP TO 24 HOURS

Ages 12 Years and Over

Tablets

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 Medtech Products Inc., owner of the registered trademark

Dramamine® All Day Less Drowsy.      50844       ORG042340319

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-403A
When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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.

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

Meclizine HCl 25 mg

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 
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

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