NON ASPIRIN EXTRA STRENGTH- acetaminophen tablet
Chain Drug Consortium

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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Drug Facts

Active ingredient

Acetaminophen 500 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 you takemore than 4000mg of acetaminophen in 24 hours 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

Ask Doctor doctor before use if you have

liver disease

Ask Doctor/Pharmacist before use if you

are 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 You may report side effects to 1-888-952-0050

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.

Directions

Adults and children 12 years of age and older: Take 2 caplets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor.

Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide. May contain povidone, and sodium starch glycolates.

Package/Label Principal Display Panel

$Z:\SPL-OTC Mono\PV\Pain Relief Caplet\APAP 24 ct carton.jpg$

NON ASPIRIN EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-139
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	AZ012
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-139-00	500 in 1 BOX; Type 0: Not a Combination Product	10/30/2014	10/01/2018
2	NDC:68016-139-01	60 in 1 BOX; Type 0: Not a Combination Product	10/30/2014	10/01/2018
3	NDC:68016-139-02	100 in 1 BOX; Type 0: Not a Combination Product	10/30/2014	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	10/30/2014	10/01/2018

Labeler - Chain Drug Consortium (101668460)

Registrant - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	label(68016-139) , manufacture(68016-139) , pack(68016-139) , relabel(68016-139) , repack(68016-139)

Revised: 10/2018

Document Id: 78d6edba-2d0b-15b5-e053-2991aa0a3d4b

Set id: 32765ada-17f8-4880-83aa-2e2bf3297f2a

Version: 2

Effective Time: 20181022

Chain Drug Consortium