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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
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 caplet)
Meclizine HCl, USP 12.5 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 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
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: 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
Other information
- Each Caplet Contains: Calcium 25 mg
- store at room temperature in a dry place
- Keep lid tightly closed
- INACTIVE INGREDIENT
Inactive ingredients
croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.
- 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
www.rugbylaboratories.com
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
RUGBYMECLIZINE 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 12.5mg 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)
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More Info on this Drug
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RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Feb 12, 2021 | 2 (current) | download |
| Mar 10, 2017 | 1 | download |
RxNorm
RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 995624 | meclizine HCl 12.5 MG Oral Tablet | PSN |
| 2 | 995624 | meclizine hydrochloride 12.5 MG Oral Tablet | SCD |
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RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
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NDC Codes
RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 68071-3063-2 (inactivated) |
| 2 | 68071-3063-3 (inactivated) |
| 3 | 68071-3063-6 (inactivated) |
| 4 | 68071-3063-9 (inactivated) |
