PAIN RELIEF EXTRA STRENGTH- acetaminophen capsule, liquid filled

Pain Relief Extra Strength by

Drug Labeling and Warnings

Pain Relief Extra Strength by is a Otc medication manufactured, distributed, or labeled by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd., Epic Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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 has liver disease.

Ask a doctor or pharmacist before use if you are taking 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

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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"

 

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"

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/06/2014

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

Registrant - Epic Pharma, LLC (827915443)

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