RELORN (acetaminophen 500 mg) Dailymed

Drug Facts

Active Ingredient (in Each Tablet):

Acetaminophen, 500 mg

Aspirin and Caffeine Free

Purpose:

Pain reliever/fever reducer

Compare to Active Ingredient in Tylenol^® Extra Strength Tablets.

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ExtraStrength TYLENOL^®.

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 which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Other Safety Information:

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

• skin reddening
• bulers
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use Section

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 have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Otc - Ask Doctor/pharmacist Section

Ask your doctor or pharmacist before use:

• if you have liver disease   
• if you are taking the blood thinning drug warfarin

Otc - Stop Use Section

Stop use:  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.

Pregnancy Or Breast Feeding:

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children

Directions:

do not take more than directed (see Overdose warning)

adults & children 12 years and over:

• take 2 tablets every 6 hours while symptoms last
• 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 at 20 - 25ºC (68 - 77ºF)

Inactive Ingredients:

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Each tablet contains 0.22 mg of Sodium.

Questions Or Comments?

1-212-594-3260, 9:00 am – 5:00 pm EST, Monday-Friday

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing.

LB-5427-06EN 200305V1.1

Tested by Ameripharma Labs, LLC, Somerset, NJ, 08873

Packaged by Unipharm, Inc., Waterbury, CT, 06705

Distributed by Unipharm, Inc., New York, NY, 10118

Made in the USA

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