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

Purpose

Antiemetic

Description

Meclizine HCl 25 mg


Medication Information

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
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

Description

Meclizine HCl 25 mg

Principal Display Panel

Do Not Use

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

Questions Or Comments?

1-800-540-3765

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
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

Principal Display Panel

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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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