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

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg


Medication Information

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
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

Description

Dimenhydrinate 50 mg

Principal Display Panel
Motion Sickness Relief
Use

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

  • nausea

  • vomiting

  • dizziness
Do Not Use

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

Questions Or Comments?

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

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

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
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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Motion Sickness Relief
Use

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

  • nausea

  • vomiting

  • dizziness
Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

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

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)