Acetaminophen Extra Strength: Package Insert and Label Information

ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated
Lidl US 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 caplet)

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

adults and children 12 years and over
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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 between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

NDC 71141-115-32

†Compare to the active ingredient in Tylenol® Extra Strength

Extra Strength

Acetaminophen

Pain Reliever/Fever Reducer

100 Caplets – 500 MG EACH

image description
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ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71141-115
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
HYPROMELLOSES
MINERAL OIL
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE
STARCH, PREGELATINIZED CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 17mm
Flavor Imprint Code M2A4;57344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71141-115-32 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (71141-115-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/31/2017
Labeler — Lidl US LLC (079389709)

Revised: 03/2017 Lidl US LLC

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