Pain Reliever: Package Insert and Label Information

PAIN RELIEVER- acetaminophen tablet
Walgreen Company

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.

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • muscular aches
    • minor pain of arthritis
  • 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.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
  • adults and children 12 years and over
    • take 2 tablets every 6 hours while symptoms persist or as directed by a doctor
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to the active ingredient in
Panadol® Extra Strength Tablets††

WALGREENS PHARMACIST RECOMMENDED

NDC 0363-1480-01

Pain Reliever ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER

Extra Strength

30 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
†† This product is not manufactured or
distributed by GlaxoSmithKline
Consumer Healthcare (UK), owner of
the registered trademark Panadol®
Extra Strength Tablets.

50844 ORG072114801

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2021 Walgreen co.

Walgreens B-2201-148-01-WDHR ORG0721
(click image for full-size original)

Walgreens B-2201-148-01-WDHR ORG0721

PAIN RELIEVER
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1480
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
STARCH, CORN
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code 44;148
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1480-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 30 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-1480-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/19/2022
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (0363-1480)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (0363-1480)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (0363-1480)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (0363-1480)

Revised: 01/2023 Walgreen Company

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