NON-ASPIRIN- acetaminophen tablet

NON-ASPIRIN by

Drug Labeling and Warnings

NON-ASPIRIN by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid LLC, Future Pak Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

Ask a doctor before use if the user has liver disease

ASK DOCTOR/PHARMACIST

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

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

GENERAL PRECAUTIONS

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

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-ASPIRIN  
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-0010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0010-1	2 in 1 PACKAGE; Type 0: Not a Combination Product	04/23/2010

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	Business Operations
Future Pak Ltd.		087737672	manufacture(52124-0010)