5172c- Rubgy - DailyMed Details

5172c- Rubgy

SPL v1

SPL

SPL Set ID 0a10016e-3fca-476d-b815-fd2abd601918

Route

ORAL

Published

Effective Date 2021-02-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Meclizine (25 mg)

Inactive Ingredients

Crospovidone Vanilla 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 FINAL Active Since 2020-10-30

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

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 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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	25 mg
30	71610-526-30
90	71610-526-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20210318JH

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

Principal Display Panel 25 Mg

NDC 71610-526 - Meclizine HCl 25 mg Tablets

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

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 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

Repackaging Information

Count	25 mg
30	71610-526-30
90	71610-526-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20210318JH

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

Principal Display Panel 25 Mg (PRINCIPAL DISPLAY PANEL - 25 mg)

NDC 71610-526 - Meclizine HCl 25 mg Tablets

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

[{"name": "CROSPOVIDONE", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VANILLA", "unii": "Q74T35078H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RASPBERRY", "unii": "4N14V5R27W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "prevents and treats nausea, vomiting or dizziness due to motion sickness", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "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", "50565-1": "Keep out of reach of children.", "51727-6": "Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "Repackaging Information": "Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 25 mg 30 71610-526-30 90 71610-526-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20210318JH", "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", "PRINCIPAL DISPLAY PANEL - 25 mg": "NDC 71610-526 - Meclizine HCl 25 mg Tablets", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:28.133372 · Updated: 2026-03-14T22:59:26.836242