Quality Choice 44-198

Quality Choice 44-198
SPL v13
SPL
SPL Set ID 98f9a8cf-cfb2-4ecc-ae90-08c4b5d1032b
Route
ORAL
Published
Effective Date 2024-09-16
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 Completed Since 1992-12-01 Until 2026-05-16

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.

Questions?

1-800-426-9391

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

Principal Display Panel

NDC 63868-034-12

QC®

QUALITY

CHOICE

Compare to the

Active Ingredient in

DRAMAMINE® ORIGINAL FORMULA*

Motion Sickness Relief

Original Formula

Dimenhydrinate 50 mg | Antiemetic

Prevents: Nausea, Vomiting & Dizziness

for Children & Adults

actual

size

24 Tablets

*This product is not manufactured or distributed by

Medtech Products Inc., owner of the registered trademark

Dramamine® Original Formula.

50844     REV0518B19808

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

100% QC

SATISFACTION

GUARANTEED

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300



 

Quality Choice 44-198

When Using This Product
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • marked drowsiness may occur

  • 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 (1-800-222-1222) 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.

Questions?

1-800-426-9391

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

Principal Display Panel

NDC 63868-034-12

QC®

QUALITY

CHOICE

Compare to the

Active Ingredient in

DRAMAMINE® ORIGINAL FORMULA*

Motion Sickness Relief

Original Formula

Dimenhydrinate 50 mg | Antiemetic

Prevents: Nausea, Vomiting & Dizziness

for Children & Adults

actual

size

24 Tablets

*This product is not manufactured or distributed by

Medtech Products Inc., owner of the registered trademark

Dramamine® Original Formula.

50844     REV0518B19808

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

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

100% QC

SATISFACTION

GUARANTEED

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300



 

Quality Choice 44-198

When Using This Product (When using this product)
  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • marked drowsiness may occur

  • 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 (1-800-222-1222) 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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