NON-ASPIRIN- acetaminophen tablet

NON-ASPIRIN by

Drug Labeling and Warnings

NON-ASPIRIN by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg

PURPOSE

pain reliever/fever reducer

INDICATIONS & USAGE

Uses: temporarily relieves minor aches and pains associated with: headaches colds toothache minor arthritis pain muscular aches menstrual cramps backache

WARNINGS

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: you take more than 8 tablets in 24 hours you take with other drugs containing acetaminophen (prescription or non-prescription) you have 3 or more alcoholic drinks every day while using this product

Do not use: with any other product containing acetaminophen for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor

When using this product do not exceed recommended dose.

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.

Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

INACTIVE INGREDIENT

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NON-ASPIRIN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-210-68	100 in 1 CARTON	04/10/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 67060-210-67	250 in 1 CARTON	04/10/2015
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/10/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-210)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-210)