PAIN RELIEVER REGULAR STRENGTH- acetaminophen tablet
FRED'S, 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.

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Freds Pharmacy 44-104

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- 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

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
redness or swelling is present
pain gets worse or lasts more than 5 days in children under 12 years
new symptoms occur
fever gets worse or lasts more than 3 days

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than directed

adults and children 12 years and over	■ take 2 tablets every 4 to 6 hours while symptoms last ■ do not take more than 10 tablets in 24 hours ■ do not take for more than 10 days unless directed by a doctor
children 6-11 years	■ take 1 tablet every 4 to 6 hours while symptoms last ■ do not take more than 5 tablets in 24 hours ■ do not take for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

fred's
Pharmacy

NDC 55315-105-12

Compare to the active ingredient in:
Regular Strength Tylenol®*

Regular Strength

PAIN RELIEVER
Acetaminophen, 325 mg
Pain Reliever/Fever Reducer

100 TABLETS

Actual
Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Regular Strength Tylenol®.
50844 REV0417A10412

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction guaranteed

Freds Pharmacy 44-104

PAIN RELIEVER REGULAR STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-105
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

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

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;104
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55315-105-12	1 in 1 CARTON	07/13/1990	04/08/2022
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	07/13/1990	04/08/2022

Labeler - FRED'S, INC. (005866116)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(55315-105)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(55315-105)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(55315-105)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(55315-105)

Revised: 6/2020

Document Id: ab30219f-1092-4af3-8e9b-21a43a4dbf4b

Set id: 58a01554-04d9-43fb-8a02-ca94c0059d02

Version: 5

Effective Time: 20200611

FRED'S, INC.