Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet
- NDC Code(s): 50844-199-02
- Packager: L.N.K. International, 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 February 11, 2021
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- Active ingredient (in each tablet)
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
When using this product
- marked drowsiness may occur
- avoid alcoholic beverages
- 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
years and over
1 to 2 tablets every 4-6 hours; do not exceed
8 tablets in 24 hours, or as directed by a
children 6 to
under 12 years
1/2 to 1 tablet every 6-8 hours; do not exceed
3 tablets in 24 hours, or as directed by a
children 2 to
under 6 years
1/2 tablet every 6-8 hours; do not exceed 1 1/2
tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
*Compare to active ingredient in Dramamine® Original Formula
Motion Sickness Relief
Dimenhydrinate 50 mg • Antiemetic
VOMITING & DIZZINESS
FOR CHILDREN & ADULTS
*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
Quality Plus 44-198
INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-199 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M, CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 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:50844-199-02 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 - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(50844-199) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(50844-199) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(50844-199) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(50844-199) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(50844-199)