dramamine chewable dimenhydrinate

SPL v1

SPL

SPL Set ID 7a43a0bb-6b0c-440a-9216-9e2eba28a06d

Route

oral

Published

Effective Date 2025-08-30

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 lake 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

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
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 ½ 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 ½ chewable 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 20-25ºC (68-77ºF)
see side panel for lot number and expiration date

Inactive Ingredients

anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Description

Dimenhydrinate 50 mg

Questions?

1-800-382-7219 Dramamine.com

ask a doctor before use.

Use

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

nausea
vomiting
dizziness

Warnin

Do not give tochildren under 12 years of age unless directed by a doctor.

Ask A D

if you are taking sedatives or tranquilizers.

Drug Facts

Package Labeling:

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 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

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 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 ½ 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 ½ chewable 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 20-25ºC (68-77ºF)
see side panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions?

1-800-382-7219 Dramamine.com

ask a doctor before use.

Use

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

nausea
vomiting
dizziness

Warnin

Do not give tochildren under 12 years of age unless directed by a doctor.

Ask A D (Ask a d)

if you are taking sedatives or tranquilizers.

Drug Facts

Package Labeling:

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 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

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6 ALUMINUM LAKE", "unii": "GYP6Z2JR6Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "8-CHLOROTHEOPHYLLINE", "unii": "GE2UA340FM", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"I": "ask a doctor before use.", "Use": "for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness", "Warnin": "Do not give to children under 12 years of age unless directed by a doctor.", "Ask a d": "if you are taking sedatives or tranquilizers.", "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 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 ½ 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 ½ chewable tablet every 6-8 hours do not give more than 1 ½ chewable tablets in 24 hours, or as directed by a doctor", "Questions?": "1-800-382-7219 Dramamine.com", "Other information": "Phenylketonurics: contains phenylalanine 0.84 mg per tablet store at room temperature 20-25ºC (68-77ºF) see side panel for lot number and expiration date", "Inactive ingredients": "anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol", "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 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.605013 · Updated: 2026-03-14T23:10:23.192014