Meclizine HCl Caplets USP

Drug Labeling and Warnings

Drug Details [pdf]

MECLIZINE HCL - meclizine hcl tablet 
Bryant Ranch Prepack

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 Caplets USP

Active Ingredient

(in each caplet)

Meclizine HCl 12.5 mg USP

Purpose

Antiemetic

Uses

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

WARNINGS

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

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating a 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 a Poison Control Center right away.

Directions

  • adults and children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other Information

  • each caplet contains: calcium 51 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

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

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

Rugby® Duluth, Georgia 30097

Meclizine Hcl 12.5mg Tablet

Label Image
MECLIZINE HCL 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63629-1789(NDC: 0536-3985)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize13mm
FlavorImprint Code AP;117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63629-1789-130 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
2NDC: 63629-1789-260 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
3NDC: 63629-1789-390 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
4NDC: 63629-1789-428 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
5NDC: 63629-1789-520 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
6NDC: 63629-1789-6120 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
7NDC: 63629-1789-7100 in 1 BOTTLE; Type 0: Not a Combination Product10/20/201004/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/14/200604/30/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1789) , RELABEL(63629-1789)

Revised: 6/2019
Document Id: 714601eb-7a2c-4e99-afe7-54a62ef0bd1a
Set id: 35ecaf2b-9a99-4af7-a349-d70138164b51
Version: 1006
Effective Time: 20190611
 
Bryant Ranch Prepack