Label: DIMENHYDRINATE tablet
- NDC Code(s): 69842-206-12, 69842-206-36
- Packager: CVS Pharmacy, Inc.
- 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 April 29, 2019
If you are a consumer or patient please visit this version.
- Drug Facts
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to an enlargement of the 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 Informations
- INACTIVE INGREDIENT
- Questions or comments?
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 Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-206 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) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) 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:69842-206-12 1 in 1 CARTON 07/03/2018 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69842-206-36 3 in 1 CARTON 07/03/2018 2 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 07/03/2018 Labeler - CVS Pharmacy, Inc. (062312574)