MECLIZINE- meclizine hcl 12.5 mg tablet 
A-S Medication Solutions

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 caplet)

Meclizine HCl 12.5mg

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 2 or 4 caplets once daily or as directed by doctor

Other information

Inactive ingredients

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions?

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

HOW SUPPLIED

Product: 50090-3017

NDC: 50090-3017-3 30 TABLET in a BOTTLE

NDC: 50090-3017-7 28 TABLET in a BOTTLE

NDC: 50090-3017-8 90 TABLET in a BOTTLE

Meclizine HCl 12.5 mg

Label Image
MECLIZINE 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3017(NDC:16103-386)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size13mm
FlavorImprint Code PH049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-3017-330 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
2NDC:50090-3017-728 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
3NDC:50090-3017-890 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/01/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-3017) , REPACK(50090-3017)

Revised: 4/2019
Document Id: 6ff5bf8e-6b92-4ee2-91d0-3f4c6cf07bab
Set id: 99b87792-f0b8-458f-9316-0d0c9e1d1684
Version: 1
Effective Time: 20190425
 
A-S Medication Solutions