MECLIZINE 25- meclizine hydrochloride tablet, chewable 
PD-Rx Pharmaceuticals, Inc.

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 25

Drug Facts

Active Ingredients (in each chewable tablet)

Meclizine 25 mg

Purpose

Antiemetic

Indications and Usage

prevents and treats nausea, vomiting, dizziness associated with motion sickness:

Warnings

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

  • ask 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 1 hour befor travel starts.

Adults and children 12 years and over:Take 1 or 2 tablets once daily, or as directed by doctor.

Inactive ingredients

Croscarmellose sodium, dextrose, FD& C Red #40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).

How Supplied

Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.

Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.

PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label


Antiemetic

Each chewable tablet contains:

Meclizine HCl

25 mg

Store at 68°-77°F (20°-25°C)

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

image

MECLIZINE 25 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-804
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code PH;051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-804-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/201711/30/2027
2NDC:43063-804-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/201811/30/2027
3NDC:43063-804-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/201811/30/2027
4NDC:43063-804-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/201811/30/2027
5NDC:43063-804-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/201811/30/2027
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/27/201711/30/2027
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-804)

Revised: 8/2020
Document Id: adde607d-d82b-2792-e053-2a95a90a25c6
Set id: cf79ac74-017e-4fb4-85d3-4ea944080e89
Version: 11
Effective Time: 20200827
 
PD-Rx Pharmaceuticals, Inc.