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 Type HUMAN OTC DRUG Item Code (Source) NDC:63629-1789(NDC:0536-3985)
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)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 13mm
Flavor Imprint Code AP;117
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63629-1789-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
2 NDC:63629-1789-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
3 NDC:63629-1789-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
4 NDC:63629-1789-4 28 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
5 NDC:63629-1789-5 20 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
6 NDC:63629-1789-6 120 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
7 NDC:63629-1789-7 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2010 04/30/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 07/14/2006 04/30/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-1789) , RELABEL(63629-1789)

Revised: 6/2019
Bryant Ranch Prepack