PHYSICIANSCARE MOTION SICKNESS- meclizine hcl tablet 
Acme United Corporation

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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PhysiciansCare Motion Sickness

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Warnings

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

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ glaucoma

■ a breathing problems such as emphysema or chronic bronchitis

Ask 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

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

(1-800-222-1222) right away.

Directions

■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity

■ to treat motion sickness, take at first signs of symptoms

Adults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Other information

■ tamper-evident sealed packets

■ do not use any opened or torn packets

■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)

■ protect from heat and humidity

■ use by expiration date on packet

Inactive ingredients

corn starch, D&C yellow # 10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Questions or comments? 1-800-835-2263

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PHYSICIANSCARE MOTION SICKNESS 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1008(NDC:47682-481)
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;403
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-1008-002 in 1 PACKET; Type 0: Not a Combination Product06/18/2021
2NDC:0924-1008-026 in 1 BAG06/18/2021
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33606/18/2021
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-1008) , repack(0924-1008)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation080119599relabel(0924-1008) , repack(0924-1008)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation117825595relabel(0924-1008) , repack(0924-1008)

Revised: 6/2021
Document Id: c4d3ea22-7c23-7311-e053-2a95a90a779c
Set id: c4d3ea22-7c22-7311-e053-2a95a90a779c
Version: 1
Effective Time: 20210618
 
Acme United Corporation