Label: MOTION SICKNESS RELIEF- dimenhydrinate 50mg tablet
- NDC Code(s): 69168-408-86
- Packager: Allegiant 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.
Drug Label Information
Updated December 12, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
-
Directions
- to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
Adults and
children 12
years and over- 1 to 2 tables every 4-6 hours
- do not exceed 8 tablets in
24 hours, or as directed by a doctor
Children 6 to
under 12 years- ½ to 1 tablet every 6-8 hours
- do not exceed 3 tablets in
24 hours, or as directed by a doctor
Children 2 to
under 6 years- ½ tablet every 6-8 hours
- do not exceed 1 ½ tablets
in 24 hours, or as directed by a doctor
- to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF
dimenhydrinate 50mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-408 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-408-86 1 in 1 CARTON 01/15/2012 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 01/15/2012 Labeler - Allegiant Health (079501930)