EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled

Extra Strength Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

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. 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

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

• skin reddening
• blisters
• rash

If a skin reaction 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
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 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 and over:
  • take 2 softgels every 6 hours while symptoms last
  • do not take more than 6 softgels in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children under 12 years:

  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

Questions or comments?

Call toll free: 1-888-423-0139

PRINCIPAL DISPLAY PANEL - Bottle Label

TopCare EXTRA STRENGTH Pain Relief

ACETAMINOPHEN 500 mg 40 SOFTGELS

NDC: 36800-414-25

*Compare to the active ingredient in TYLENOL® Extra Strength

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-414
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 (clear)	Score	no score
Shape	capsule (oblong)	Size	27mm
Flavor		Imprint Code	PC24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-414-25	40 in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/11/2016

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(36800-414) , analysis(36800-414)