Extra Strength Pain Relief: Package Insert and Label Information

EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled
PuraCap Pharmaceutical LLC

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.

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: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

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Extra Strength Pain Relief

Acetaminophen 500 mg 80 SOFTGELS

NDC 51013-182-26

*Compare to the active ingredient in TYLENOL® Extra Strength

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EXTRA STRENGTH PAIN RELIEF
acetaminophen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLENE GLYCOL
WATER
SORBITOL
Product Characteristics
Color red (clear) Score no score
Shape capsule (oblong) Size 27mm
Flavor Imprint Code PC24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51013-182-26 80 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/01/2016
Labeler — PuraCap Pharmaceutical LLC (962106329)
Establishment
Name Address ID/FEI Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 manufacture (51013-182), analysis (51013-182)

Revised: 01/2020 PuraCap Pharmaceutical LLC

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