Label: RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-3063-2, 68071-3063-3, 68071-3063-6, 68071-3063-9 - Packager: NuCare Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-1017
- 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 February 11, 2021
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- 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
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INGREDIENTS AND APPEARANCE
RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3063(NDC:0536-1017) 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 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) Product Characteristics Color white Score 2 pieces Shape CAPSULE (modified capsule shaped uncoated tablet with bisect) Size 3mm Flavor Imprint Code 19G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3063-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017 2 NDC:68071-3063-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017 3 NDC:68071-3063-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017 4 NDC:68071-3063-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 03/07/2014 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3063)