5172c- Rubgy

5172c- Rubgy
SPL v9
SPL
SPL Set ID f2390098-efb7-4cfb-879b-fe4524daf886
Route
ORAL
Published
Effective Date 2024-07-30
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

How Supplied

Product: 50090-5952 NDC: 50090-5952-0 30 TABLET, CHEWABLE in a BOTTLE


Medication Information

How Supplied

Product: 50090-5952

NDC: 50090-5952-0 30 TABLET, CHEWABLE in a BOTTLE

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

Meclizine Hydrochloride
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)

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

How Supplied (HOW SUPPLIED)

Product: 50090-5952

NDC: 50090-5952-0 30 TABLET, CHEWABLE in a BOTTLE

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

Meclizine Hydrochloride (MECLIZINE HYDROCHLORIDE)
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

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