Label: DIMENHYDRINATE tablet
- NDC Code(s): 70000-0404-1
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 5, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
Do not give to children under 2 years of age unless directed by a doctor
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
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
■ 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
- INACTIVE INGREDIENT
- Questions or comments?
SPL UNCLASSIFIED SECTION
*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
© 2018 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
Essential to Care™ since 1979
All LEADER™ Brand
Products Have A
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0404 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 1006;1006 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0404-1 1 in 1 CARTON 01/04/2019 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 01/04/2019 Labeler - Cardinal Health (097537435)