MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
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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5172C- Rubgy

Drug Facts

Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

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

 Do not exceed recommended dosage

 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 a Poison Control Center right away (1-800-222-1222).

Directions

 Dosage should be taken one hour before travel starts

adults and children 12
years of age and over
chew 1 to 2 tablets once daily, or as directed by a doctor
children under
12 years of age
do not give this product to children under 12 years of age
unless directed by a doctor

Other information

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

 store at room temperature in a dry place

 keep lid tightly closed

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Questions or comments?

1-800-645-2158

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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

*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com

HOW SUPPLIED

NDC: 71335-2177-1: 30 Tablets in a BOTTLE

NDC: 71335-2177-2: 20 Tablets in a BOTTLE

NDC: 71335-2177-3: 25 Tablets in a BOTTLE

NDC: 71335-2177-4: 40 Tablets in a BOTTLE

NDC: 71335-2177-5: 60 Tablets in a BOTTLE

NDC: 71335-2177-6: 90 Tablets in a BOTTLE

NDC: 71335-2177-7: 8 Tablets in a BOTTLE

NDC: 71335-2177-8: 14 Tablets in a BOTTLE

NDC: 71335-2177-9: 10 Tablets in a BOTTLE

NDC: 71335-2177-0: 120 Tablets in a BOTTLE

Meclizine 25MG Chewable

Label
MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-2177(NDC:0536-1299)
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
CROSPOVIDONE (UNII: 2S7830E561)  
VANILLA BEAN (UNII: Q74T35078H)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
RASPBERRY (UNII: 4N14V5R27W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorpink (Rosy) Score2 pieces
ShapeROUNDSize9mm
FlavorVANILLA, RASPBERRYImprint Code 5172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-2177-130 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
2NDC:71335-2177-220 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
3NDC:71335-2177-325 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
4NDC:71335-2177-440 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
5NDC:71335-2177-560 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
6NDC:71335-2177-690 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
7NDC:71335-2177-78 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
8NDC:71335-2177-814 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
9NDC:71335-2177-910 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
10NDC:71335-2177-0120 in 1 BOTTLE; Type 0: Not a Combination Product10/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/30/2020
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-2177) , RELABEL(71335-2177)

Revised: 4/2023
Document Id: 601056fd-b652-4ce6-beaf-b0d48f489743
Set id: cd82fca9-a8dc-4545-8e64-b67d644832e7
Version: 102
Effective Time: 20230425
 
Bryant Ranch Prepack