RELORN- acetaminophen tablet

RELORN by

Drug Labeling and Warnings

RELORN by is a Otc medication manufactured, distributed, or labeled by UNIPHARM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each tablet):

Acetaminophen, 500 mg

Aspirin and Caffeine Free

Purpose:

Pain reliever/fever reducer

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Compare to Active Ingredient in Tylenol® Extra Strength Tablets.

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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
• blisters
• rash

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

DO NOT USE

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.

ASK DOCTOR/PHARMACIST

Ask your doctor or pharmacist before use:

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

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

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

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

LB-5427-06EN 200305V1.1

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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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RELORN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62900-542
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	5427
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62900-542-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/19/2020

Labeler - UNIPHARM, INC. (884789132)