5172c- Rubgy - DailyMed Details

5172c- Rubgy

SPL v2

SPL

SPL Set ID 199ae195-4556-ee88-e063-6394a90a40d4

Route

ORAL

Published

Effective Date 2024-06-10

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 Silicon Dioxide Fd&c Red No. 40 Lactose Monohydrate Saccharin Sodium Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance

Imprint: 5172 Shape: round Color: pink Size: 9 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG 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

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

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

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

 Store in a dry place at 15°-30°C (59°-86°F)

 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 drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC 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:

25mg

NDC 71610-836-30, Bottles of 30 Tablets

NDC 71610-836-53, Bottles of 60 Tablets

NDC 71610-836-60, Bottles of 90 Tablets

NDC 71610-836-80, Bottles of 180 Tablets

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

20240529AMH

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 25mg

NDC 71610-836 - Meclizine 25mg Tablets - Rx Only

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)

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

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

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)

 Store in a dry place at 15°-30°C (59°-86°F)

 keep lid tightly closed

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Repackaging Information (REPACKAGING INFORMATION)

25mg

NDC 71610-836-30, Bottles of 30 Tablets

NDC 71610-836-53, Bottles of 60 Tablets

NDC 71610-836-60, Bottles of 90 Tablets

NDC 71610-836-80, Bottles of 180 Tablets

Cookeville, TN 38506

20240529AMH

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 25mg (PRINCIPAL DISPLAY PANEL - 25mg)

NDC 71610-836 - Meclizine 25mg Tablets - Rx Only

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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®. Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 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": " Store in a dry place at 15°-30°C (59°-86°F)  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 drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC 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: 25mg NDC 71610-836-30, Bottles of 30 Tablets NDC 71610-836-53, Bottles of 60 Tablets NDC 71610-836-60, Bottles of 90 Tablets NDC 71610-836-80, Bottles of 180 Tablets 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 20240529AMH", "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 - 25mg": "NDC 71610-836 - Meclizine 25mg Tablets - Rx Only", "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: 2026-02-15T12:03:09.467515 · Updated: 2026-03-14T23:03:02.507799