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

Purpose

Antiemetic

Description

Meclizine HCl 12.5 mg


Medication Information

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.

Uses

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

Purpose

Antiemetic

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

Description

Meclizine HCl 12.5 mg

Section 51945-4

Rugby®

NDC 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

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

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.

Uses

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

Purpose

Antiemetic

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

Section 51945-4 (51945-4)

Rugby®

NDC 0536-1297-10

Meclizine 

12.5mg

Antiemetic

1000 Caplets

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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