Label: RUGBY- rugby tablet
- 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.
Updated March 7, 2014
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredient (in each caplet)
Meclizine HCl, USP 12.5 mgClose
- INDICATIONS & USAGE
prevents and treats nausea, vomiting or dizziness due to motion sicknessClose
Do not use in children under 12 years of age unless directed by a doctor
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
Ask 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 machinery
If 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.Close
- DOSAGE & ADMINISTRATION
Dosage should be taken one hour before travel starts.Close
Adults and children 12 years of age and older: take 2-4 caplets once daily, or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
- STORAGE AND HANDLING
Each Caplet Contains: Calcium 25 mgClose
store at room temperature in a dry place
Keep lid tightly closed
- INACTIVE INGREDIENT
croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.Close
Questions or comments?
- OTHER SAFETY INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGClose
- SPL UNCLASSIFIED SECTION
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233
Livonia, MI 48152
- OTC KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF THE REACH OF CHILDRENClose
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product 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)