MECLIZINE HYDROCHLORIDE- meclizine hcl tablet 
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.

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hpc 778au (478)

Active ingredient (in each tablet)

Meclizine HCI 25mg

Purpose

Antiemetic

Uses

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

Warnings

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

Ask a doctor before use if you have

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery
I f 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

  • to prevent motion sickness, take the first dose 1/2 to 1 hour before starting activity
  • not for frequent or prolonged use except on the advice of a doctor
  • Adults and children 12 years of age and over: Take 1-2 tablets once daily, or as directed by a doctor.

Do not exceed 2 tablets in 24 hours

Other information

TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

• store at room temperature 15˚-30˚C (59˚-86˚F)

• protect from humidity

Inactive ingredients

D&C yellow # 10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica

package label

1

MECLIZINE HYDROCHLORIDE 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-478
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize9mm
FlavorImprint Code AM4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-478-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/202108/31/2023
Labeler - NORTHEAST PHARMA (081232935)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2022
 
NORTHEAST PHARMA