Drug Facts
Active ingredient (in each tablet)
Dimenhydrinate 50 mg
Dimenhydrinate Tablet
FDA Label NDC 70000-0404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Leader/ Cardinal Health 110, Inc. for the product Dimenhydrinate (NDC 70000-0404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiemetic
Uses
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
Warnings
Do not give to children under 2 years of age unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
■ marked drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ use caution when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 Information
■ each tablet contains: calcium 29 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ protect from moisture
■ see end flap for expiration date and lot number
■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
Inactive Ingredient
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
1-800-231-4670
Other
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
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Package Label.Principal Display Panel
LEADER
NDC 7000-0404-1
Original Formula
Motion Sickness Relief
Dimenhydrinate, 50 mg/ Antiemetic
COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient*
Fast Acting Motion Sickness Relief for Children & Adults
12 Tablets
* Please review the disclaimer below.
