Label: PHYSICIANSCARE DIMENHYDRINATE MOTION SICKNESS RELIEF- dimenhydrinate tablet, coated
- NDC Code(s): 0924-1006-01, 0924-1006-02
- Packager: Acme United Corporation
- 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 December 12, 2017
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- Drug Facts
Do not use for children under 2 years of age unless directed by a doctor
Ask doctor before use if you have
•breathing problem such as emphysema or chronic bronchitis
•trouble urinatining due to an enlarged prostate gland.
When using this product
•marked drowsiness may occur
•avoid alcoholic drinks
•alcohol, sedatives and tranquilizers may increase drowsiness
•be careful when driving a motor vehicle or operating machinery.
To prevent motion sickness the first dose should be taken 1/2 to 1 hour before starting activity.
To prevent or treat motion sickness:
Adults and children: (12 years and older): take 1 -2 tablets every 4 - 6 hours, not more than 8 tablets in 24 hours, or as directed by doctor Children 6 to under 12 years: give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by a doctor. Children 2 to under 6 years: give ¼ to 1/2 tablet every 6 - 8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Carton Label
- Packet Label
- Bag Label
INGREDIENTS AND APPEARANCE
PHYSICIANSCARE DIMENHYDRINATE MOTION SICKNESS RELIEF
dimenhydrinate tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 1006;1006 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-1006-01 50 in 1 CARTON 10/05/2013 03/31/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-1006-02 6 in 1 BAG 10/05/2013 03/31/2023 2 2 in 1 PACKET; 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 10/05/2013 03/31/2023 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-1006) , repack(0924-1006)