Drug Facts

Active ingredient (in each capsule)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg 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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user hasliver disease.

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 and over	take 2 softgels every 4 to 6 hours while symptoms last do not take more than 6 softgels in 24 hours unless directed by a doctor do not take more than 10 days unless diredted by doctor
Children 12 years of age	ask a doctor

Other information

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

ACETAMINOPHEN CAPSULES, 500 mg

Quantity : 3000 Capsules
NDC. No : 53345-019-01

IMP ORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Shipping Label

PRINCIPAL DISPLAY PANEL - Shipping Label

ACETAMINOPHEN CAPSULES, 500 mg

Quantity : 3000 Capsules
NDC. No : 53345-019-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

PAIN RELIEF EXTRA STRENGTH
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53345-019
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE (oblong)	Size	24mm
Flavor		Imprint Code	PC24
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53345-019-01	1 in 1 BOX	01/06/2014
1		3000 in 1 BAG; Type 0: Not a Combination Product
2	NDC:53345-019-02	1 in 1 BOX	01/06/2014
2		2000 in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	01/06/2014

Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

Registrant - Epic Pharma, LLC (827915443)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	manufacture(53345-019)