PAIN RELIEVER- acetaminophen tablet, film coated

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

• headache
• toothache
• minor arthritis pain
• muscular aches
• the common cold
• menstrual cramps

For the reduction of fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets 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

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.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

• liver disease

Ask a doctor or pharmacist before use if you are

• you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

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 use more than directed

• Adults and children 12 years and over:

  Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

• Children under 12 years:

  Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• store at room temperature 59 ̊-86 ̊F (15 ̊-30 ̊C)
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY
PLUS†

NDC: 50844-270-24

†Compare to active ingredient in Extra Strength Tylenol®

EXTRA STRENGTH
PAIN RELIEVER
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER

CONTAINS NO ASPIRIN

60 Packets
of 2 Tablets each
500 mg each

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF PACKET IS TORN, BROKEN OR SHOWS ANY SIGNS
OF TAMPERING

†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.

50844 ORG

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive Hauppauge, NY 11788 USA

44-745

INGREDIENTS AND APPEARANCE

PAIN RELIEVER 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-270
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
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	44;745
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50844-270-24	60 in 1 CARTON	11/14/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/14/2019

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(50844-270)