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- Contains inactivated NDC Code(s)
NDC Code(s): 12634-246-00, 12634-246-01, 12634-246-71, 12634-246-79, view more12634-246-80, 12634-246-85, 12634-246-91, 12634-246-96
- Packager: Apotheca Inc.
- 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 December 29, 2015
If you are a consumer or patient please visit this version.
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- Active ingredient(in each chewable tablet)
- Purpose
Antiemetic
- Uses
- prevents and treats nausea, vomiting or dizziness due to motion sickness
- prevents and treats nausea, vomiting or dizziness due to motion sickness
- 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 gland
Ask a doctor or pharmacist before use it 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
Keep out of reach of children.
In case of overdose, get medical help or contact the poison control center immediately.
- Directions
Dosage should be taken one hour before travel starts
Adults and children 12 years of age and older:
Chew 1-2 tablets 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
- Other information
- Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
- store at room temperature
- Inactive ingredients
aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.
- Questions or comments?
1-800-645-2158
- OTHER SAFETY INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
RUGBY TRAVEL SICKNESSMECLIZINE HCL, 25 MG EACH (ANTIEMETIC)
meclizine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12634-246(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 25mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (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:12634-246-00 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:12634-246-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:12634-246-71 30 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:12634-246-79 25 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:12634-246-80 20 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:12634-246-85 15 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:12634-246-91 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 8 NDC:12634-246-96 6 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/19/2014 Labeler -Apotheca Inc.(051457844)
Establishment Name Address ID/FEI Business Operations Apotheca Inc. 051457844 relabel(12634-246) , repack(12634-246)
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More Info on this Drug
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View Labeling Archives for this drug
RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Dec 29, 2015 | 1 (current) | download |
RxNorm
RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 995632 | meclizine HCl 25 MG Chewable Tablet | PSN |
| 2 | 995632 | meclizine hydrochloride 25 MG Chewable Tablet | SCD |
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RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable
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NDC Codes
RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 12634-246-00 (inactivated) |
| 2 | 12634-246-01 (inactivated) |
| 3 | 12634-246-71 (inactivated) |
| 4 | 12634-246-79 (inactivated) |
| 5 | 12634-246-80 (inactivated) |
| 6 | 12634-246-85 (inactivated) |
| 7 | 12634-246-91 (inactivated) |
| 8 | 12634-246-96 (inactivated) |
