dimenhydrinate tablets, usp 50 mg

SPL v2

SPL

SPL Set ID 637179aa-13ca-4116-a15f-c170b1eded4c

Route

oral

Published

Effective Date 2012-12-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (50 mg)

Inactive Ingredients

silicon dioxide lactose monohydrate magnesium stearate cellulose, microcrystalline sodium starch glycolate type a potato stearic acid

Identifiers & Packaging

Pill Appearance

Imprint: 0111;V Shape: round Color: white Size: 9 mm Score: 2

Marketing Status

otc monograph final active Since 2004-03-01

Purpose

Antiemetic

Description

Dimenhydrinate 50 mg

Medication Information

Active Ingredient

Dimenhydrinate 50 mg

Indications and Usage

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

nausea
vomiting
dizziness

Purpose

Antiemetic

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, use the following dosing

adults and children 12 years and over	1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
children 6 years to under 12 years	1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
children 2 years to under 6 years	1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Description

Dimenhydrinate 50 mg

Section 42229-5

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA

Rev. 8/09 R4 8080234 0111

Section 50568-5

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

Section 50570-1

in children under 2 years of age unless directed by a doctor Do not use

Section 53414-9

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

Dimenhydrinate

When Using This Product

marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 right away. (1-800-222-1222).

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Dimenhydrinate 50 mg

Indications and Usage (34067-9)

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

nausea
vomiting
dizziness

Purpose

Antiemetic

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, use the following dosing

adults and children 12 years and over	1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
children 6 years to under 12 years	1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
children 2 years to under 6 years	1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Information (Other information)

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811

Inactive Ingredients (Inactive ingredients)

colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Section 42229-5 (42229-5)

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA

Rev. 8/09 R4 8080234 0111

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

in children under 2 years of age unless directed by a doctor Do not use

Section 53414-9 (53414-9)

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

Dimenhydrinate

When Using This Product (When using this product)

marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
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 right away. (1-800-222-1222).

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
difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "for prevention and treatment of these symptoms associated with motion sickness: Uses nausea vomiting dizziness", "42229-5": "Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA Rev. 8/09 R4 8080234 0111", "50568-5": "taking sedatives or tranquilizers Ask a doctor or pharmacist before use if you are", "50570-1": "in children under 2 years of age unless directed by a doctor Do not use", "53414-9": "ask a health professional before use. If pregnant or breast-feeding,", "Purpose": "Antiemetic", "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, use the following dosing adults and children 12 years and over 1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor children 6 years to under 12 years 1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor children 2 years to under 6 years 1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor ", "Other information": "store at 15° to 30°C (59° to 86°F) You may report serious side effects to: . 130 Vintage Drive, Huntsville, AL 35811", "Inactive ingredients": "colloidal silicone dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid", "When using this product": "marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks 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 right away. (1-800-222-1222).", "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 difficulty in urination due to enlargement of the prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.783294 · Updated: 2026-03-14T22:53:46.796959