MECLIZINE HYDROCHLORIDE- meclizine hcl tablet, chewable 
NORTHEAST PHARMA

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.

----------

hpc 779

Active ingredient (in each chewable tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of these symptoms associated
with motion sickness • nausea • vomiting • dizziness

Warnings

Do not use

for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

  • glaucoma
  • breathing problems, such as emphysema or chronic bronchitis
  • difficulty 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

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic beverages 
  • 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.

Directions

Other information

Inactive ingredients

corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

Questions or comments?

1-800-540-3765

Principal Display Panel

1

MECLIZINE HYDROCHLORIDE 
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-779
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
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScore2 pieces
ShapeROUNDSize9mm
FlavorRASPBERRYImprint Code 44;404
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-779-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/01/2022
Labeler - NORTHEAST PHARMA (081232935)
Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

Revised: 11/2022
Document Id: eea1e7ec-1ce0-02e3-e053-2a95a90aed44
Set id: eea1e7ec-1cdf-02e3-e053-2a95a90aed44
Version: 1
Effective Time: 20221122
 
NORTHEAST PHARMA