Meclizine Hydrochloride Chewable Tablets 25 Mg

Meclizine Hydrochloride Chewable Tablets 25 Mg
SPL v2
SPL
SPL Set ID 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc
Route
ORAL
Published
Effective Date 2022-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Aspartame Croscarmellose Sodium Dextrose Fd&c Red No. 40 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Raspberry Silicon Dioxide Sodium Sulfate Anhydrous Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: M Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-18

Description

Meclizine HCl, USP 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl, USP 25 mg

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

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

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Directions
  • Dosage should be taken one hour before travel starts
  • Adults and children 12 years and older: Chew 1-2 tablets once daily, or as directed by a doctor
  • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

Drug Facts

Meclizine HCl, USP 25 mg

Other Information
  • Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
  • Store at room temperature in a dry place
  • Keep lid tightly closed
Inactive Ingredients

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions Or Comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

When Using This Product
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery
Keep Out of Reach of Children.

In case of overdose, get medical help or contact the Poison Control Center immediately.

Principal Display Panel 25 Mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

Tamper Evident: Do Not Use If Foil Seal Under Cap, Printed With"sealed for Your Protection" Is Broken Or Missing.


Structured Label Content

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antiemetic

Warnings

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

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Directions
  • Dosage should be taken one hour before travel starts
  • Adults and children 12 years and older: Chew 1-2 tablets once daily, or as directed by a doctor
  • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

Drug Facts

Meclizine HCl, USP 25 mg

Other Information
  • Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
  • Store at room temperature in a dry place
  • Keep lid tightly closed
Inactive Ingredients (Inactive ingredients)

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions Or Comments? (Questions or comments?)

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

When Using This Product (When using this product)
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact the Poison Control Center immediately.

Principal Display Panel 25 Mg Chewable Tablet Label (PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label)

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

Tamper Evident: Do Not Use If Foil Seal Under Cap, Printed With"sealed for Your Protection" Is Broken Or Missing. (TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.)


Advanced Ingredient Data


Raw Label Data

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