Dimenhydrinate Tablets, Usp 50 Mg

Dimenhydrinate Tablets, Usp 50 Mg
SPL v2
SPL
SPL Set ID 637179aa-13ca-4116-a15f-c170b1eded4c
Route
ORAL
Published
Effective Date 2012-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Silicon Dioxide Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 0111;V Shape: round Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2004-03-01
Description

Dimenhydrinate 50 mg

Purpose

Antiemetic

Medication Information

Indications and Usage

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

  • nausea
  • vomiting
  • dizziness
Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Section 42229-5

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA



Rev. 8/09 R4 8080234 0111

Section 50568-5

taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are

Section 50570-1

in children under 2 years of age unless directed by a doctor Do not use

Section 53414-9

ask a health professional before use. If pregnant or breast-feeding,

Directions
  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
  • to prevent or treat motion sickness, use the following dosing

adults and children 12 years and over 

1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor 

children 6 years to under 12 years 

1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor 

children 2 years to under 6 years 

1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor 

Dimenhydrinate
Other Information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

When Using This Product
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

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

Structured Label Content

Indications and Usage (34067-9)

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

  • nausea
  • vomiting
  • dizziness
Section 42229-5 (42229-5)

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA



Rev. 8/09 R4 8080234 0111

Section 50568-5 (50568-5)

taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are

Section 50570-1 (50570-1)

in children under 2 years of age unless directed by a doctor Do not use

Section 53414-9 (53414-9)

ask a health professional before use. If pregnant or breast-feeding,

Purpose

Antiemetic

Directions
  • to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
  • to prevent or treat motion sickness, use the following dosing

adults and children 12 years and over 

1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor 

children 6 years to under 12 years 

1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor 

children 2 years to under 6 years 

1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor 

Dimenhydrinate
Other Information (Other information)

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients (Inactive ingredients)

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

When Using This Product (When using this product)
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
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. (1-800-222-1222).

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.783294 · Updated: 2026-03-14T22:53:46.796959