Hpc 779

Hpc 779
SPL v2
SPL
SPL Set ID eea1e7ec-1cdf-02e3-e053-2a95a90aed44
Route
ORAL
Published
Effective Date 2022-04-07
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 Active Since 2022-11-01

Description

Meclizine HCl 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 25 mg

Uses

For the prevention and treatment of these symptoms associated

with motion sickness • nausea • vomiting • dizziness

Directions
  • do not exceed recommended dose
  • 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 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 imprinted seal under cap is broken or missing.
  • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from humidity
Inactive Ingredients

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

Questions Or Comments?

1-800-540-3765

Principal Display Panel

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
  • glaucoma
  • breathing problems, such as emphysema or chronic bronchitis
  • difficulty urinating due to an enlarged prostate gland
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 the prevention and treatment of these symptoms associated

with motion sickness • nausea • vomiting • dizziness

Purpose

Antiemetic

Directions
  • do not exceed recommended dose
  • 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 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 imprinted seal under cap is broken or missing.
  • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from humidity
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?)

1-800-540-3765

Principal Display Panel

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)
  • glaucoma
  • breathing problems, such as emphysema or chronic bronchitis
  • difficulty urinating due to an enlarged prostate gland
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

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