Pain Relief Extra Strength: Package Insert and Label Information

PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated
MARC GLASSMAN, INC.

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 tablet)

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 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 tablets 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

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Marc’s®

NDC 68998-392-01

†Compare to the active ingredient in Tylenol® Extra Strength Coated Tablets

Extra Strength • For Adults

Pain Relief

Acetaminophen

PAIN RELIEVER / FEVER REDUCER

• Sweet Coated Tablets

• Contains No Aspirin

Actual Size

100 COATED TABLETS — 500 MG EACH

PAIN RELIEF EXTRA STRENGTH acetaminophen tablet, coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-392 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 ACESULFAME POTASSIUM FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 6 HYPROMELLOSES POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE STARCH, PREGELATINIZED CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE

Product Characteristics Color red Score no score Shape ROUND Size 11mm Flavor Imprint Code A92 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68998-392-01 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 (68998-392-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 10/05/2022

Labeler — MARC GLASSMAN, INC. (094487477)

Revised: 10/2022 MARC GLASSMAN, INC.