5172c- Rubgy

5172c- Rubgy
SPL v5
SPL
SPL Set ID 54731aaf-d413-4976-b040-40c8e3e7eafd
Route
ORAL
Published
Effective Date 2025-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Crospovidone, Unspecified Vanilla Bean Magnesium Stearate Raspberry Stearic Acid Fd&c Red No. 40 Lactose Monohydrate Saccharin Sodium Croscarmellose Sodium Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 5172 Shape: round Color: pink Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-19 Until 2022-08-26

Description

Active ingredient (in each chewable tablet) Meclizine HCl 25 mg


Medication Information

Description

Active ingredient (in each chewable tablet) Meclizine HCl 25 mg

Uses

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

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Repackaged By: Preferred Pharmaceuticals Inc.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Section 51945-4

Rugby

NDC 68788-7873

Compare to the active ingredient in Bonine®*

Meclizibe 25 mg

Antiemetic

Chewable Tablets

Preferred Pharmaceuticals Inc.

Section 53414-9

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

Section 55105-1

Purpose



Antiemetic

Directions

 Dosage should be taken one hour before travel starts

  •  
    adults and children 12

    years of age and over

chew 1 to 2 tablets once daily, or as directed by a doctor

  •  
    children under

    12 years of age
  •  
    do not give this product to children under 12 years of age

    unless directed by a doctor
Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl 25 mg

Do Not Use In

children under 12 years of age unless directed by a doctor

Other Information

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

 store at room temperature in a dry place

 keep lid tightly closed

Questions Or Comments?

1-800-645-2158

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

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

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers


Structured Label Content

Uses

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

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 42229-5 (42229-5)

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Repackaged By: Preferred Pharmaceuticals Inc.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Section 51945-4 (51945-4)

Rugby

NDC 68788-7873

Compare to the active ingredient in Bonine®*

Meclizibe 25 mg

Antiemetic

Chewable Tablets

Preferred Pharmaceuticals Inc.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose



Antiemetic

Directions

 Dosage should be taken one hour before travel starts

  •  
    adults and children 12

    years of age and over

chew 1 to 2 tablets once daily, or as directed by a doctor

  •  
    children under

    12 years of age
  •  
    do not give this product to children under 12 years of age

    unless directed by a doctor
Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl 25 mg

Do Not Use In (Do not use in)

children under 12 years of age unless directed by a doctor

Other Information (Other information)

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

 store at room temperature in a dry place

 keep lid tightly closed

Questions Or Comments? (Questions or comments?)

1-800-645-2158

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

Ask A Doctor Before Use If You Have (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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)