Label: PHYSICIANSCARE MOTION SICKNESS- meclizine hcl tablet
- NDC Code(s): 0924-1008-00, 0924-1008-02
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 47682-481
- 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 June 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity
■ to treat motion sickness, take at first signs of symptoms
Adults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PHYSICIANSCARE MOTION SICKNESS
meclizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1008(NDC:47682-481) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) Product Characteristics Color yellow Score no score Shape ROUND Size 9mm Flavor Imprint Code 44;403 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-1008-00 2 in 1 PACKET; Type 0: Not a Combination Product 06/18/2021 2 NDC:0924-1008-02 6 in 1 BAG 06/18/2021 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 06/18/2021 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-1008) , repack(0924-1008) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-1008) , repack(0924-1008) Establishment Name Address ID/FEI Business Operations Acme United Corporation 117825595 relabel(0924-1008) , repack(0924-1008)