Quality Plus 44-198

Quality Plus 44-198
SPL v11
SPL
SPL Set ID 95aae32f-6b3f-469d-86a5-c201a53f862a
Route
ORAL
Published
Effective Date 2025-06-11
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 ½ 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 ½ tablet every 6-8 hours; do not exceed 1½ 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
  • see end flap for expiration date and lot number
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
  • protect from moisture

Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QUALITY

    +PLUS

NDC 50844-199-02

*Compare to active ingredient in

Dramamine® Original Formula

ORIGINAL FORMULA

Motion Sickness Relief

Dimenhydrinate 50 mg •  Antiemetic

PREVENTS NAUSEA,

VOMITING & DIZZINESS

FOR CHILDREN & ADULTS

12

Tablets

ACTUAL

SIZE

*This product is not manufactured or distributed by Medtech Products Inc., owner

of the registered trademark Dramamine® Original Formula.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844   REV0518B19802

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-198
When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • use caution when driving a motor vehicle or operating machinery 
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 ½ 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 ½ tablet every 6-8 hours; do not exceed 1½ 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
  • see end flap for expiration date and lot number
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
  • protect from moisture

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QUALITY

    +PLUS

NDC 50844-199-02

*Compare to active ingredient in

Dramamine® Original Formula

ORIGINAL FORMULA

Motion Sickness Relief

Dimenhydrinate 50 mg •  Antiemetic

PREVENTS NAUSEA,

VOMITING & DIZZINESS

FOR CHILDREN & ADULTS

12

Tablets

ACTUAL

SIZE

*This product is not manufactured or distributed by Medtech Products Inc., owner

of the registered trademark Dramamine® Original Formula.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844   REV0518B19802

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-198
When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • use caution when driving a motor vehicle or operating machinery 
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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