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Pac-Kit Motion Sickness

Dosage form: tablet, coated
Ingredients: DIMENHYDRINATE 50mg
Labeler: Acme United Corporation
NDC Code: 0924-0014

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.

1006 - Acme (Pac-Kit)

Active Ingredient (in each tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

For prevention and treatment of

  • nausea
  • vomiting, or
  • dizziness associated with motion sickness

Warnings:

ALCOHOL WARNING: Do not use alcoholic beverages while taking this product. May cause marked drowsiness: alcohol, sedatives and tranquilizers may increase the dowsiness effect

DO NOT USE UNLESS DIRECTED BY YOUR PHYSICIAN IF

  • You are using prescription drugs
  • You are using sedatives or tranquilizers
  • You are currently under a doctor's care
  • You have glaucoma
  • You have emphysema
  • You have chronic pulmonary disease
  • You have shortness of breath or difficulty in breathing
  • You have difficulty in urination due to enlargement of the prostate gland

When using this product

Use the smallest effective dose
Do not use more than directed. This product is not for frequent or prolonged use unless on the advice of a doctor
Use caution when driving a motor vehicle or operating machinery

STOP USING AND ASK A DOCTOR IF

  • Nervousness, dizziness or sleeplessness occur
  • Conditions worsen or new symptoms occur

Keep this and all medicines out of the reach of children.Do not exceed recommended dose. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. If you are pregnant or nursing a baby, as with any drug, seek the advice of a health professsional before using this product.

Directions for use:

  • TAMPER EVIDENT PACKAGE. DO NOT USE IF WRAPPER IS OPEN OR TORN. Do not use if the expiration date on the package has passed. Do not give to children under 2 years of age unless directed by a physician.

Adults:

1 to 2 tablets with water every 4 to 6 hours, not to exceed 8 tablets in 24 hours.
Children 6 to under 12 years of age:½ to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours.
Children 2 to under 6 years of age:1/2 tablet every 6 to 8 hours under 6 years of age: not to exceed 1-1/2 tablets in 24 hours.

Other information:

  • ´╗┐Storage: Keep in a dry place, do not expose to excessive heat.

Inactive ingredients:

croscarmellose sodium, magnesium stearate, microcrystalline celluslose, dicalcium phosphate

Questions about this product:

´╗┐Call 800-243-5050 with any questions about this product

Bag Label


Pouch Label

PAC-KIT MOTION SICKNESS 
dimenhydrinate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (DIPHENHYDRAMINE) DIMENHYDRINATE50 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code1006;1006
Contains    
Packaging
#Item CodePackage Description
1NDC:0924-0014-026 PACKET in 1 BAG
12 TABLET, COATED in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/21/201306/30/2019
Labeler - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIOperations
Acme United Corporation045924339relabel(0924-0014), repack(0924-0014)

 
Acme United Corporation

Medically reviewed on Dec 12, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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