Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 3a6b8c81-cfb8-4194-a9ad-ed0db19b72a9
Route
ORAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Dextrose, Unspecified Form Fd&c Red No. 40 Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Saccharin Sodium Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH051 Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-01

Description

Meclizine HCl 25mg

Purpose

Antiemetic

How Supplied

Product: 50090-2652 NDC: 50090-2652-0 30 TABLET, CHEWABLE in a BOTTLE


Medication Information

Purpose

Antiemetic

How Supplied

Product: 50090-2652

NDC: 50090-2652-0 30 TABLET, CHEWABLE in a BOTTLE

Description

Meclizine HCl 25mg

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

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

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

Directions
  • doage should be taken 1 hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Questions?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

Other Information
  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)
Meclizine Hcl 25mg
Inactive Ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

When Using This Product
  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful 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 25mg


Structured Label Content

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Purpose

Antiemetic

Warnings

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

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

Directions
  • doage should be taken 1 hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Questions?

Adverse drug event call (866) 562-2756 (M - F, 8AM - 4PM EST).

How Supplied (HOW SUPPLIED)

Product: 50090-2652

NDC: 50090-2652-0 30 TABLET, CHEWABLE in a BOTTLE

Other Information (Other information)
  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)
Meclizine Hcl 25mg (Meclizine HCl 25mg)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful 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 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)