dramamine chewable orange

dramamine chewable orange
SPL v6
SPL
SPL Set ID 76166156-bce1-492f-833e-6bbd07859c3f
Route
oral
Published
Effective Date 2025-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
8-chlorotheophylline (50 mg)
Inactive Ingredients
anhydrous citric acid aspartame fd&c yellow no. 6 aluminum oxide magnesium stearate maltodextrin sorbitol

Identifiers & Packaging

Pill Appearance
Shape: round Color: orange Size: 12 mm Score: 2
Marketing Status
otc monograph drug active Since 2012-01-15

Purpose

Antiemetic

Description

Drug Facts


Medication Information

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 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 ½ to 1 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 ½ tablet every 6-8 hours

  • do not give more than 1 ½ chewable tablets

    in 24 hours, or as directed by a doctor
Other Information
  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet

  • store at room temperature 68-77ºF (20-25ºC)

  • do not use if carton is opened or if blister is broken or torn

  • see side 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

Description

Drug Facts

Principal Display Panel

Dimenhydrinate Tablets/Antiemetic

CHEWABLE FORMULA

Dramamine®

MOTION SICKNESS RELIEF

DUAL ACTION

1. TREATS SYMPTOMS ON THE SPOT

2. PREVENTS NAUSEA, DIZZINESS & VOMITING

Convenient Chewable Tablets

8 ORANGE FLAVORED TABLETS (50 mg EACH)

I

ask a doctor before use.

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

Ask A D

if you are taking sedatives or tranquilizers

Active Ingredient

(in each tablet)

Dimenhydrinate 50 mg

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
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.

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

Structured Label Content

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 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 ½ to 1 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 ½ tablet every 6-8 hours

  • do not give more than 1 ½ chewable tablets

    in 24 hours, or as directed by a doctor
Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet

  • store at room temperature 68-77ºF (20-25ºC)

  • do not use if carton is opened or if blister is broken or torn

  • see side 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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Dimenhydrinate Tablets/Antiemetic

CHEWABLE FORMULA

Dramamine®

MOTION SICKNESS RELIEF

DUAL ACTION

1. TREATS SYMPTOMS ON THE SPOT

2. PREVENTS NAUSEA, DIZZINESS & VOMITING

Convenient Chewable Tablets

8 ORANGE FLAVORED TABLETS (50 mg EACH)

I

ask a doctor before use.

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

Ask A D (Ask a d)

if you are taking sedatives or tranquilizers

Active Ingredient (Active ingredient)

(in each tablet)

Dimenhydrinate 50 mg

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
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.

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)