MECLIZINE HCl, USP 12.5 mg CAPLETS

Rugby by

Drug Labeling and Warnings

Rugby by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet 
A-S Medication Solutions

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.

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MECLIZINE HCl, USP 12.5 mg CAPLETS

Drug Facts

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses

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 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.

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

Other information

• Each Caplet Contains: Calcium 25 mg
• store at room temperature in a dry place
• Keep lid tightly closed

Inactive ingredients

croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

Questions or comments?

call 1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

HOW SUPPLIED

Product: 50090-2243

Meclizine HCl

RUGBY  MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-2243(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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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: 50090-2243-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2015	11/30/2018
2	NDC: 50090-2243-7	28 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2015	11/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	03/07/2014	11/30/2018

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2243) , REPACK(50090-2243)

Revised: 1/2020

Document Id: 188e2de8-b09b-4f2c-b779-336ba09bad73

34390-5

Set id: a49af7f3-9f86-4821-96d8-ed35b6e0e4df

Version: 5

Effective Time: 20200118

 

A-S Medication Solutions