Label: RUGBY tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-1252-3 - Packager: RedPharm Drug, 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 March 7, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use in children under 12 years of age unless directed by a doctor
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 glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machineryIf pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact the poison control center immediately.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- OTC KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RUGBY
rugby tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1252(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 MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP) SODIUM SULFATE (UNII: 0YPR65R21J) 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:67296-1252-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 03/07/2014 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations RedPharm Drug Inc. 828374897 relabel(67296-1252) , repack(67296-1252)
