DIMENHYDRINATE TABLETS, USP 50 mg

Set ID
637179aa-13ca-4116-a15f-c170b1eded4c
Manufacturer
Carilion Materials Management
Effective date
2012-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:41

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

Warnings

OTC - DO NOT USE SECTION

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions And Dosage

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 Label Information

Inactive ingredients

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

Dimenhydrinate

Products

NDC Codes

Ingredients

NameUNIIKind
DIMENHYDRINATEJB937PER5CACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT

Complete SPL Sections

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dimenhydrinate 50 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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 INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Made in the for Qualitest Pharmaceuticals Huntsville, AL 35811 USA Rev. 8/09 R4 8080234 0111

Dimenhydrinate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/637179aa-13ca-4116-a15f-c170b1eded4c/37dba1f7-1117-4a6e-afe5-e8684883ae2c.xml
XML SHA-256
93c77682aecd719a4640a9645bf3b28296c18c7523b31d5096d3144733c918e5
XML bytes
23688

Legacy File Index

FolderFileDate
otc37dba1f7-1117-4a6e-afe5-e8684883ae2c.xml2014-07-07
otc68151-1712.jpg2014-07-07