Dramamine Original Formula

Dramamine Original Formula
SPL v3
SPL
SPL Set ID 7b0aa993-f08f-4dff-a82d-f35b3ebe3cc1
Route
ORAL
Published
Effective Date 2019-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-15

Description

Dimenhydrinate 50 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Use

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 ½ to 1 hour before starting activity

Adults and

children 12


years and over
  • 1 to 2 tables 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 1 ½ 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 35mg
  • do not use ifblister unit is torn or open
  • store at room temperature 68-77ºF (20-25ºC)
  • protect from moisture
Inactive Ingredients

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

Questions Or Comments?

1-888-952-0050 (Monday through Friday 9AM - 5PM EST)

Principal Display Panel
Motion Sickness Relief
When Using This Product
  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase dizziness

  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

In case of accidental 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

  • 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

Use

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 ½ to 1 hour before starting activity

Adults and

children 12


years and over
  • 1 to 2 tables 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 1 ½ 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 35mg
  • do not use ifblister unit is torn or open
  • store at room temperature 68-77ºF (20-25ºC)
  • 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?)

1-888-952-0050 (Monday through Friday 9AM - 5PM EST)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Motion Sickness Relief
When Using This Product (When using this product)
  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase dizziness

  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental 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

  • trouble urinating due to an enlarged 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

All Sections (JSON)