ACETAMINOPHEN PAIN RELIEF - acetaminophen tablet
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Acetaminophen Tablet

*Compared to the active ingredient in Extra-Strength Tylenol® Tablets

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 500 mg

PURPOSES

Pain Reliever/Fever Reducer

Keep Out of Reach of Children

Keep out of reach of children

USES

temporarily relieves minor aches and pains
temporarily relieves reduces 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

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.

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.

OVERDOSAGE

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. 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

Age	Dose
Adults and Children 12 years and over	Take 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years	Do not use.

OTHER INFORMATION

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

store at 20°-25°C (68°-77°F)
for institutional use only

INACTIVE INGREDIETNS:

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

Distributor Information:

*This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63rd St., Brooklyn, New York 11204

This Product was Repackaged By Sandhills Packaging For:

Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States

Image of Label

ACETAMINOPHEN PAIN RELIEF
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	49999-099 (57896-201)
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
POVIDONE
STARCH, CORN
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	M2A4;57344
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	49999-099-20	20 TABLET In 1 BOTTLE, PLASTIC	None
2	49999-099-30	30 TABLET In 1 BOTTLE, PLASTIC	None
3	49999-099-60	60 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	02/02/2023

Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC		831276758	repack, relabel

Revised: 02/2012Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC