MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
PD-Rx Pharmaceuticals, Inc.

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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 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

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

HOW SUPPLIED

Each round chewable pink scored tablet imprinted with 5172 has a vanilla raspberry smell.

Bottles of 12 NDC 72789-250-12

Bottles of 20 NDC 72789-250-20

Bottles of 30 NDC 72789-250-30

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Keep container tightly closed. Dispense in a tight, light-resistant container, as defined in the USP using a child-resistant closure.

Meclizibe 25 mg

Antiemetic

72789250 Label

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-250(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 (UNII: Q74T35078H)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
RASPBERRY (UNII: 4N14V5R27W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorpink (Rosy) Score2 pieces
ShapeROUNDSize9mm
FlavorVANILLA, RASPBERRYImprint Code 5172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72789-250-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
2NDC:72789-250-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
3NDC:72789-250-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00910/30/2020
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(72789-250)

Revised: 10/2023
Document Id: 06c1c1ef-4024-7e97-e063-6294a90a5723
Set id: a9ad5d27-306d-48ca-a10d-0a0415d08f05
Version: 4
Effective Time: 20231002
 
PD-Rx Pharmaceuticals, Inc.