AYPANAL- acetaminophen tablet AYPANAL NON-ASPIRIN- acetaminophen tablet

Aypanal Non-Aspirin by

Drug Labeling and Warnings

Aypanal Non-Aspirin by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to the common cold and headache
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin rash occurs, stop use and seek medical help right away.

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.

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 using and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

If pregnant 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.

Overdose warning: In case of accidental 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

• do not take more than directed (see overdose warning)
• adults and children 12 years of age or older

• take two tablets every 4-6 hours while symptoms last
• do not take more than 12 tablets in 24 hours

• children 6 to under 12 years of age
• take 1 tablet every 4-6 hours while symptoms last
• do not take more than 5 tablets in 24 hours
• children under 6 years
• consult a doctor

Other information

• store at room temperature 15 o to 30 oC (59 o - 86 oF)
• TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Inactive ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-430-5490

North Aypanal

Honeywell Aypanal

INGREDIENTS AND APPEARANCE

AYPANAL 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-2000
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)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (White)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Circle;U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2000-06	26 in 1 BOX, UNIT-DOSE	04/10/2012	01/01/2017
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-2000-05	50 in 1 BOX, UNIT-DOSE	04/10/2012	01/01/2017
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-2000-10	100 in 1 BOX, UNIT-DOSE	04/10/2012	01/01/2017
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0498-2000-25	250 in 1 BOX, UNIT-DOSE	04/10/2012	01/01/2017
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0498-2000-50	500 in 1 BOX, UNIT-DOSE	04/10/2012	01/01/2017
5		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	04/10/2012	01/01/2017

AYPANAL NON-ASPIRIN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-2001
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
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	circle;U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2001-10	100 in 1 BOX	01/02/2017
1	NDC: 0498-2001-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-2001-03	25 in 1 BOX	01/02/2017
2	NDC: 0498-2001-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-2001-25	250 in 1 BOX	01/02/2017
3	NDC: 0498-2001-01	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0498-2001-50	500 in 1 BOX	01/02/2017
4	NDC: 0498-2001-01	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	01/02/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Registrant - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-2001, 0498-2000)