Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet
- NDC Code(s): 36800-930-12
- Packager: Topco Associates, LLC
- 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 January 17, 2023
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
- Uses
-
Warnings
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
-
Directions
- to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
adults and children 12 years and over 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to
under 12 years½ 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 years½ tablet every 6-8 hours; do not
exceed 1½ tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
TopCare®
health™NDC 36800-930-12
COMPARE TO DRAMAMINE® ORIGINAL
FORMULA ACTIVE INGREDIENT*ORIGINAL FORMULA
Motion Sickness Relief
DIMENHYDRINATE, 50 mg - ANTIEMETIC
Prevents Nausea, Dizziness & Vomiting
12 TABLETS
For Children & Adults
actual size
*This product is not manufactured or distributed by Medtech
Products Inc., owner of the registered trademark Dramamine®
Original Formula. 50844 REV0518B19802DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.comTAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING -
INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-930 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, 8-CHLOROTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 44;198 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-930-12 2 in 1 CARTON 12/01/1992 1 6 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 12/01/1992 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(36800-930) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(36800-930) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(36800-930) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(36800-930) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(36800-930)