MECLIZINE- meclizine hcl 25mg 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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Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use for children under 12 years of age unless directed by a doctor.

Do not take unless directed by a doctor if you have

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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

Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other information

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 (800) 687-0176 (M - F, 8AM - 4PM EST).

HOW SUPPLIED

Product: 71335-1215

NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE

Meclizine 25MG Chewable

Label Image
MECLIZINE 
meclizine hcl 25mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1215(NDC:66424-387)
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)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorpink (LIGHT PINK COLOR) Score2 pieces
ShapeROUND (ROUND TABLET) Size8mm
FlavorImprint Code PH051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1215-0120 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
2NDC:71335-1215-130 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
3NDC:71335-1215-220 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
4NDC:71335-1215-325 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
5NDC:71335-1215-440 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
6NDC:71335-1215-560 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
7NDC:71335-1215-690 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
8NDC:71335-1215-78 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
9NDC:71335-1215-814 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
10NDC:71335-1215-910 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/01/2018
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1215) , RELABEL(71335-1215)

Revised: 6/2019
Document Id: dc78e0fc-fccc-45a2-a33b-2a2eeb5caab9
Set id: 623db9de-4224-47ce-84b7-6eaefe97290e
Version: 1
Effective Time: 20190613
 
Bryant Ranch Prepack