Dramamine Original Formula

Dramamine Original Formula
SPL v8
SPL
SPL Set ID f9302a5a-295a-4501-9332-e3f5eb387362
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
8-chlorotheophylline (50 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Drug Facts

Use

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

  • nausea

  • vomiting

  • dizziness
Do Not

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

Section 42229-5

Drug Facts

Directions
  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity

  • to prevent or treat motion sickness, see below:
Adults and

children 12


years and over
  • take 1 to 2 tables every 4-6 hours

  • do not take more than 8 tablets in

    24 hours, or as directed by a doctor
Children 6 to

under 12 years
  • give ½ to 1 tablet every 6-8 hours

  • do not give more than 3 tablets in

    24 hours, or as directed by a doctor
Children 2 to

under 6 years
  • give ½ tablet every 6-8 hours

  • do not give more than 1 ½ tablets

    in 24 hours, or as directed by a doctor
Active Ingredient

(in each tablet)

Dimenhydrinate 50 mg

Other Information
  • store at room temperature 20-25ºC (68-77ºF) 
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

Call 1-800-382-7219

Dramamine.com

Principal Display Panel

Dramamine®

motion sickness 

Original

Dimenhydrinate tablets/antiemetic

12 tablets (50 mg each)

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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
Do Not (Do not)

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antiemetic

Directions
  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity

  • to prevent or treat motion sickness, see below:
Adults and

children 12


years and over
  • take 1 to 2 tables every 4-6 hours

  • do not take more than 8 tablets in

    24 hours, or as directed by a doctor
Children 6 to

under 12 years
  • give ½ to 1 tablet every 6-8 hours

  • do not give more than 3 tablets in

    24 hours, or as directed by a doctor
Children 2 to

under 6 years
  • give ½ tablet every 6-8 hours

  • do not give more than 1 ½ tablets

    in 24 hours, or as directed by a doctor
Active Ingredient (Active ingredient)

(in each tablet)

Dimenhydrinate 50 mg

Other Information (Other information)
  • store at room temperature 20-25ºC (68-77ºF) 
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose

Questions Or Comments? (Questions or comments?)

Call 1-800-382-7219

Dramamine.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dramamine®

motion sickness 

Original

Dimenhydrinate tablets/antiemetic

12 tablets (50 mg each)

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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

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