Dramamine®

Dramamine®
SPL v1
SPL
SPL Set ID ec76597c-eb6a-4025-9d64-fb79c2daca51
Route
ORAL
Published
Effective Date 2022-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: orange Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL 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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50568-5

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

Section 53414-9

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

Warnings

Do not give to children under 2 years of age unless directed by a doctor

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, see below:
adults and children 12 years and over
  • take 1 to 2 chewable tablets every 4-6 hours
  • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years
  • give 1/2 to 1 chewable tablet every 6-8 hours
  • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years
  • give 1/2 chewable tablet every 6-8 hours
  • do not give more than 1½ chewable tablets in 24 hours, or as directed by a doctor
Other Information
  • Phenylketonurics: contains phenylaline 0.84 mg per tablet
  • store at room tempurature 20°- 25°C (68°-77°F)
  • do not use if pouch is opened
  • see bottom of this panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions Or Comments?

call 1-800-382-7219

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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
Principal Display Panel 50 Mg Tablet Packet Carton

#1

Pharmacist

Recommended

BRAND

DIMENHYDRINATE

TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting

TO OPEN

PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets

(50 mg each)


Structured Label Content

Use

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

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

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Purpose

Antiemetic

Warnings

Do not give to children under 2 years of age unless directed by a doctor

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, see below:
adults and children 12 years and over
  • take 1 to 2 chewable tablets every 4-6 hours
  • do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years
  • give 1/2 to 1 chewable tablet every 6-8 hours
  • do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years
  • give 1/2 chewable tablet every 6-8 hours
  • do not give more than 1½ chewable tablets in 24 hours, or as directed by a doctor
Other Information (Other information)
  • Phenylketonurics: contains phenylaline 0.84 mg per tablet
  • store at room tempurature 20°- 25°C (68°-77°F)
  • do not use if pouch is opened
  • see bottom of this panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions Or Comments? (Questions or comments?)

call 1-800-382-7219

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
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
Principal Display Panel 50 Mg Tablet Packet Carton (PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton)

#1

Pharmacist

Recommended

BRAND

DIMENHYDRINATE

TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,

Dizziness and Vomiting

TO OPEN

PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets

(50 mg each)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)