RUGBYMECLIZINE HCL, 12.5 MG EACH ANTIEMETIC MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet 
REMEDYREPACK INC.

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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Drug Facts

OTC - ACTIVE INGREDIENT

Meclizine HCl USP 12.5 mg

 

OTC - PURPOSE

Antiemetic

 

INDICATIONS & USAGE

  • prevents and treats nausea, vomiting or dizziness due to motion sickness

 

WARNINGS

 

  • 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.

 

  • 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.

 

In case of overdose, get medical help or contact the poison control center immediately.

 

DOSAGE & ADMINISTRATION

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

 

SPL UNCLASSIFIED

  • store at room temperature
  • Each Caplet Contains: Calcium 25 mg
  • Each Caplet Contains: Sodium 5mg

 

INACTIVE INGREDIENT

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

 

OTC - QUESTIONS

1-800-645-2158

 

OTHER SAFETY INFORMATION

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

 

OTC - KEEP OUT OF REACH OF CHILDREN



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: RugbyMeclizine HCl, 12.5 mg Each ANTIEMETIC Meclizine HCl, 12.5 mg Each ANTIEMETIC


GENERIC: Meclizine HCl


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 61786-099-02


ACTIVE INGREDIENT(S):

  • MECLIZINE HYDROCHLORIDE 12.5mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • SODIUM SULFATE
  • CROSCARMELLOSE SODIUM
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
  • MAGNESIUM STEARATE
  • STEARIC ACID


COLOR: white


SHAPE: CAPSULE


SCORE: Two even pieces


SIZE: 3 mm


IMPRINT: 19G


PACKAGING: 30 in 1 BLISTER PACK




MM1

MM2

RUGBYMECLIZINE HCL, 12.5 MG EACH ANTIEMETIC  MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61786-099(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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE (TABLET) Size 3mm
Flavor Imprint Code 19G
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61786-099-02 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/21/2014 12/30/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 11/21/2014 12/30/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2017
REMEDYREPACK INC.