Label: MOTION SICKNESS- dimenhydrinate tablet
- NDC Code(s): 55315-630-12
- Packager: Freds 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 10, 2014
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- Active ingredient (in each tablet)
Dimenhydrinate 50 mgClose
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.Close
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
a dults and children 12 years 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 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 1/4 to 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 30 mg
- store at room temperature 20º-25ºC (68º-77ºF)
- Inactive ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline celluloseClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- PRINCIPAL DISPLAY PANEL
Dimenhydrinate 50 mg/Antiemetic
Fast Acting Motion Sickness Relief
For Children and Adults
Tablets 50 mg Each
Compare to the active ingredient in Dramamine®*
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Original Formula.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATIONClose
- Product Label
Fred's Motion Sickness Tablets
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 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:55315-630-12 1 in 1 CARTON 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 07/08/2010 Labeler - Freds Inc (005866116) Registrant - P and L Development of New York Corporation (800014821)