Label: MOTION SICKNESS RELIEF- dimenhydrinate tablet
- NDC Code(s): 63868-034-12, 63868-034-24
- Packager: CHAIN DRUG MARKETING ASSOCIATION 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 September 12, 2022
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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 over1 to 2 tablets every 4-6 hours;
do not exceed 8 tablets in 24 hours,
or as directed by a doctorchildren 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 doctorchildren 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?
-
Principal Display Panel
NDC 63868-034-12
QC®
QUALITY
CHOICECompare to the
Active Ingredient in
DRAMAMINE® ORIGINAL FORMULA*Motion Sickness Relief
Original Formula
Dimenhydrinate 50 mg | AntiemeticPrevents: Nausea, Vomiting & Dizziness
for Children & Adultsactual
size24 Tablets
*This product is not manufactured or distributed by
Medtech Products Inc., owner of the registered trademark
Dramamine® Original Formula.
50844 REV0518B19808TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING100% QC
SATISFACTION
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Questions: 248-449-9300
Quality Choice 44-198
-
INGREDIENTS AND APPEARANCE
MOTION SICKNESS RELIEF
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-034 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:63868-034-24 4 in 1 CARTON 12/01/1992 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63868-034-12 2 in 1 CARTON 12/01/1992 2 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 - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(63868-034) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(63868-034) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(63868-034) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(63868-034) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(63868-034)