Topcare 44-198

Topcare 44-198
SPL v10
SPL
SPL Set ID 503a70db-d564-4ea0-851e-8ff617e70728
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
8-chlorotheophylline (50 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;198 Shape: round Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 1992-12-01

Description

Dimenhydrinate 50 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Directions
  • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and children 12 years and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years 1/2 tablet every 6-8 hours; do not exceed 1&1/2 tablets in 24 hours, or as directed by a doctor
Do Not Use

for children under 2 years of age unless directed by a doctor.

Other Information
  • each tablet contains: calcium 35 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments?

1-888-423-0139

Principal Display Panel

TopCare®

health

NDC 36800-930-12

COMPARE TO DRAMAMINE® ORIGINAL

FORMULA ACTIVE INGREDIENT*

ORIGINAL FORMULA

Motion Sickness Relief

DIMENHYDRINATE, 50 mg - ANTIEMETIC

Prevents Nausea, Dizziness & Vomiting

12 TABLETS

For Children & Adults

actual size

*This product is not manufactured or distributed by Medtech

Products Inc., owner of the registered trademark Dramamine®

Original Formula.          50844    REV0518C19802

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0923 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

TopCare 44-198

When Using This Product
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

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.

Active Ingredient (in Each Tablet)

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Purpose

Antiemetic

Directions
  • to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and children 12 years and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years 1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years 1/2 tablet every 6-8 hours; do not exceed 1&1/2 tablets in 24 hours, or as directed by a doctor
Do Not Use (Do not use)

for children under 2 years of age unless directed by a doctor.

Other Information (Other information)
  • each tablet contains: calcium 35 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (Principal display panel)

TopCare®

health

NDC 36800-930-12

COMPARE TO DRAMAMINE® ORIGINAL

FORMULA ACTIVE INGREDIENT*

ORIGINAL FORMULA

Motion Sickness Relief

DIMENHYDRINATE, 50 mg - ANTIEMETIC

Prevents Nausea, Dizziness & Vomiting

12 TABLETS

For Children & Adults

actual size

*This product is not manufactured or distributed by Medtech

Products Inc., owner of the registered trademark Dramamine®

Original Formula.          50844    REV0518C19802

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0923 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN

OR SHOWS ANY SIGNS OF TAMPERING

TopCare 44-198

When Using This Product (When using this product)
  • marked drowsiness may occur

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Dimenhydrinate 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

  • difficulty in urination due to enlargement of the prostate gland

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

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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