Label: RUGBY MECLIZINE HCL- meclizine hydrochloride tablet, film coated
- NDC Code(s): 0536-1178-01, 0536-1178-10
- Packager: RUGBY LABORATORIES
- Category: HUMAN OTC DRUG LABEL
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 November 11, 2020
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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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RUGBY MECLIZINE HCL
meclizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1178 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (Film Coated) Score 2 pieces Shape CAPSULE (Modified) Size 13mm Flavor Imprint Code 19G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1178-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/20/2018 07/31/2022 2 NDC:0536-1178-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/20/2018 07/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 04/20/2018 07/31/2022 Labeler - RUGBY LABORATORIES (079246066)