Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f2581bc8-7845-4c65-b5cf-fbce48768fb9
Route
ORAL
Published
Effective Date 2019-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (12.5 mg)
Inactive Ingredients
Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH049 Shape: capsule Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-02-01

Description

Meclizine HCl 12.5mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 12.5mg

Uses

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

Section 51945-4

NDC 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

SDA

LABORATORIES

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 2 or 4 caplets once daily or as directed by doctor

Questions?

Adverse drug event call (800) 687-0176 (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)
Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, 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 Caplet)

Meclizine HCl 12.5mg


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

NDC 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

SDA

LABORATORIES

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 2 or 4 caplets once daily or as directed by doctor

Questions?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

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)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, 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 Caplet) (Active ingredient (in each caplet))

Meclizine HCl 12.5mg


Advanced Ingredient Data


Raw Label Data

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