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- NDC Code(s): 71610-245-30, 71610-245-60
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- 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 March 14, 2019
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Active ingredient (in each chewable tablet)
Meclizine HCl USP 25 mg
- PURPOSE
-
Uses prevents and treats nausea, vomiting or dizziness due to motion sickness
- 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 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
- STORAGE AND HANDLING
Other information
- Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
- Store at room temperature in a dry place
- Keep lid tightly closed
- INACTIVE INGREDIENT
Inactive ingredients
aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.
- QUESTIONS
Questions or comments?
call 1-800-645-2158
- OTHER SAFETY INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- SPL UNCLASSIFIED SECTION
Distributed by: Rugby Laboratories
17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152
- Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 25 mg 30 71610-245-30 90 71610-245-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 3850620190314JH
- PRINCIPAL DISPLAY PANEL - 25 mg
NDC 71610-245 - Meclizine HCl (Travel Sickness) 25 mg Chewable Tablets
- 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:71610-245(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:71610-245-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2019 2 NDC:71610-245-60 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/19/2014 Labeler -Aphena Pharma Solutions - Tennessee, LLC(128385585)
Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-245)
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More Info on this Drug
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RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC)- meclizine hcl tablet, chewable
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Mar 22, 2019 | 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 | 71610-245-30 |
| 2 | 71610-245-60 |
