Label: MOTION SICKNESS- dimenhydrinate tablet
- NDC Code(s): 50804-198-02
- Packager: Geiss, Destin & Dunn 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.
Drug Label Information
Updated March 6, 2023
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- 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
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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 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 1½ tablets in 24 hours, or as directed by a doctor
- to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
GoodSense®
NDC 50804-198-02
Original Formula
Motion Sickness
Dimenhydrinate 50 mg
AntiemeticPrevents Nausea, Vomiting & Dizziness
for Children & Adults12 Tablets
actual size
*Compare to the active ingredient in
Dramamine® Original Formula100%
SATISFACTION
GUARANTEEDTAMPER 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 Medtech
Products Inc., owner of the registered trademark Dramamine® Original
Formula. 50844 ORG051819802Distributed by: Geiss, Destin & Dunn, Inc., A Perrigo Company
Peachtree City, GA 30269
www.PerrigoDirect.com
(1-800-426-9391)
GoodSense® is a registered trademark of L. Perrigo Company.GoodSense 44-198
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INGREDIENTS AND APPEARANCE
MOTION SICKNESS
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-198 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:50804-198-02 2 in 1 CARTON 04/07/2020 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 04/07/2020 Labeler - Geiss, Destin & Dunn Inc. (076059836) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(50804-198) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(50804-198) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50804-198) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(50804-198) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(50804-198)