Label: TRAVEL SICKNESS MECLIZINE HCL- meclizine hcl tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 50436-3989-1 - Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 0536-1018
- 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 5, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE
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INGREDIENTS AND APPEARANCE
TRAVEL SICKNESS MECLIZINE HCL
meclizine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-3989(NDC:0536-1018) 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 ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) SUCROSE (UNII: C151H8M554) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color pink Score 2 pieces Shape ROUND (Biconvex Uncoated Tablet with Bisect) Size 8mm Flavor Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-3989-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/19/2014 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-3989)