Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8a234ce3-eb6b-49dd-9d78-7fc7bdd49d35
Route
ORAL
Published
Effective Date 2024-12-20
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: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-21

Description

Meclizine HCl 12.5 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl 12.5 mg

Uses

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

Section 51945-4

Rugby®

NDC 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

Warnings

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

Do not take this product, unless directed by a doctor, if you have

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

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

Directions
  • dosage should be taken one hour before travel starts 
adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by a doctor

Other Information
  • each caplet contains:  calcium 28 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product
  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 (1-800-222-1222).

Active Ingredient (in Each Caplet)

Meclizine HCl 12.5 mg


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Rugby®

NDC 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

Purpose

Antiemetic

Warnings

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

Do not take this product, unless directed by a doctor, if you have

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

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

Directions
  • dosage should be taken one hour before travel starts 
adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by a doctor

Other Information (Other information)
  • each caplet contains:  calcium 28 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 (1-800-222-1222).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Meclizine HCl 12.5 mg


Advanced Ingredient Data


Raw Label Data

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