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Handy Solutions Acetaminophen

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-161

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.

Handy Solutions Acetaminophen

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

For the temporary relief of minor aches and pains associated with:

• headache • muscular aches • minor arthritis pain • common cold • toothache • menstrual cramps

For the reduction of fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain, unless directed by a doctor
  • for more than 3 days for fever, unless directed by a doctor

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years of age: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information
  • Tamper evident. Do not ues if packet is torn, cut or opened
  • Store at controlled room temperatures 15° to 30° C (59 to 86°F)

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain

Questions or comments?

call 1-800-525-5097

Package Labeling:

HANDY SOLUTIONS ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-161(NDC:47682-125)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSE, UNSPECIFIED 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint CodeFR;33
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-161-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/21/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

Revised: 09/2016
 
Navajo Manufacturing Company Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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