1006-CVS

Set ID
6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56
Manufacturer
CVS Pharmacy, Inc.
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:55

Key Label Information

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each tablet) Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

Antiemetic

Uses

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Directions And Dosage

Directions

■ to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

1-800-231-4670

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth Compare to the active ingredient in Dramamine® Original Formula* Motion Sickness DIMENHYDRINATE TABLETS Antiemetic Original formula • Fast acting motion sickness relief • For children & adults 36 TABLETS (50 mg EACH)

Products

NDC Codes

Ingredients

NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
DIMENHYDRINATEJB937PER5CACTIB

Complete SPL Sections

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Dimenhydrinate 50 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Directions

DOSAGE & ADMINISTRATION SECTION

■ to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Informations

OTHER SAFETY INFORMATION

■ each tablet contain s: calcium 30 mg ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) ■ protect from moisture

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING * This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2021 CVS/pha rmacy CVS.com® 1-800-SHOP CVS V-30287

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth Compare to the active ingredient in Dramamine® Original Formula* Motion Sickness DIMENHYDRINATE TABLETS Antiemetic Original formula • Fast acting motion sickness relief • For children & adults 36 TABLETS (50 mg EACH)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/6dfc5cb4-af0c-56c9-e053-2a91aa0a5d56/28512065-3533-f58a-e063-6394a90a7dfa.xml
XML SHA-256
2e4ccbec8cc5a8b53a4bd80ad495e66a2cec2c337f4381a959c9b82e755fe82e
XML bytes
27394

Legacy File Index

FolderFileDate
otc28512065-3533-f58a-e063-6394a90a7dfa.xml2024-12-08
otc1006-36BB-CVS-R50554.jpg2021-11-19
otcd114c3af-521e-a2e8-e053-2a95a90a0151.xml2021-11-19
otc1006-36BB_12644_IFC_CVS.jpg2020-11-14
otcb4042d77-f740-479d-e053-2995a90a1d8c.xml2020-11-14
otc1006-36BB.jpg2019-05-02
otc87b21496-0dd1-717c-e053-2995a90a516b.xml2019-05-02