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Name:Non-aspirin
Manufacturer:Genuine First Aid Llc
Category:Over-the-counter (OTC) Marketed Drugs


NON-ASPIRIN Acetaminophen 325mg

NON-ASPIRIN   - acetaminophen tablet 
Genuine First Aid LLC

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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NON-ASPIRIN Acetaminophen 325mg

Active Ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Analgesic/antipyretic

Uses


temporary relief of minor aches and pains associated with:

common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever

Warnings

Liver warning:   This product contains acetaminophen.

Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 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 the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of accidental overdose, contact a doctor 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.  Do not exceed recommended dosage

Inactive Ingredients

Cornstarch, polyethylene glycol, stearic acid, povidone

Directions

Adults and Children                        Take 2 tablets every 4 to 6 hours as

12 years of age                               needed.  Do not take more than 12 tablets

or older                                          in 24 hours.



Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

of age                                               needed.  Do not take more than 5

                                                        tablets in 24 hours.



Children under 6                                Do not use this regular strength product.

years of age                                      This will provide more than the

                                                         recommended dose (overdose) and could

                                                         cause serious health problems.

Store at 59-86 degree F (15-30 degree C)


tamper evident sealed packets; do not use any open or torn packets

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

GENUINE FIRST AID         2 Tablets

NON-ASPIRIN

Non Aspirin


NON-ASPIRIN  
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-0010
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
POLYETHYLENE GLYCOL  
STEARIC ACID  
POVIDONE  
Product Characteristics
Color white (WHITE) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AZ;234
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52124-0010-1 2 TABLET ( TABLET) in 1 PACKAGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/23/2010

Labeler - Genuine First Aid LLC (619609857)
Establishment
Name Address ID/FEI Operations
Future Pak Ltd. 087737672 manufacture

Revised: 05/2011 Genuine First Aid LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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