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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Travel Sickness

Active Ingredient

(in each tablet)

Meclizine HCl 25 mg 

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 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

  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water
  • adults & children 12 years and over: 1-2 tablets once daily

    children under 12 years: ask a doctor

Other Information

  • phenylketonurics: each tablet contains: phenylalanine 0.28mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or Comments

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

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

Rugby® Duluth, Georgia 30097

HOW SUPPLIED

Product: 63629-4008

NDC: 63629-4008-1 30 TABLET in a BOTTLE

NDC: 63629-4008-2 20 TABLET in a BOTTLE

NDC: 63629-4008-3 25 TABLET in a BOTTLE

NDC: 63629-4008-4 40 TABLET in a BOTTLE

NDC: 63629-4008-5 60 TABLET in a BOTTLE

NDC: 63629-4008-6 90 TABLET in a BOTTLE

NDC: 63629-4008-7 8 TABLET in a BOTTLE

NDC: 63629-4008-8 14 TABLET in a BOTTLE

NDC: 63629-4008-9 10 TABLET in a BOTTLE

NDC: 63629-4008-0 120 TABLET in a BOTTLE

Meclizine 25MG Chewable

Label Image
MECLIZINE HCL 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-4008(NDC:0536-3990)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ASPARTAME (UNII: Z0H242BBR1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
RASPBERRY (UNII: 4N14V5R27W)  
Product Characteristics
ColorREDScore2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code AP;115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4008-325 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
2NDC:63629-4008-0120 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
3NDC:63629-4008-130 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
4NDC:63629-4008-440 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
5NDC:63629-4008-560 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
6NDC:63629-4008-814 in 1 BOTTLE; Type 0: Not a Combination Product06/19/200903/15/2018
7NDC:63629-4008-690 in 1 BOTTLE; Type 0: Not a Combination Product06/19/200903/15/2018
8NDC:63629-4008-910 in 1 BOTTLE; Type 0: Not a Combination Product06/19/200903/15/2018
9NDC:63629-4008-220 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/15/2018
10NDC:63629-4008-78 in 1 BOTTLE; Type 0: Not a Combination Product06/19/200903/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/22/200803/15/2018
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4008) , RELABEL(63629-4008)

Revised: 6/2021
Document Id: 0ecca1dc-cf6f-4cd8-a1f8-e6d5e0fade82
Set id: 31791f62-2700-4ffb-bced-4a27159d0b8c
Version: 1003
Effective Time: 20210630
 
Bryant Ranch Prepack