ACETAMINOPHEN by H.J. Harkins Company, Inc. ACETAMINOPHEN tablet

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 500 mg

PURPOSE

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

• temporarily relieves minor aches and pains
• temporarily 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 symptom 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.

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.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

• do not take more than directed
• adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
• children under 12 years: do not use

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

OTHER SAFETY INFORMATION

• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
• store at 20⁰C-25⁰C (68⁰F-77⁰F)
• for institutional use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-002
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, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	M2A457344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-002-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
2	NDC: 52959-002-14	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
3	NDC: 52959-002-15	15 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
4	NDC: 52959-002-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
5	NDC: 52959-002-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
6	NDC: 52959-002-25	25 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
7	NDC: 52959-002-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
8	NDC: 52959-002-40	40 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
9	NDC: 52959-002-42	42 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
10	NDC: 52959-002-45	45 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
11	NDC: 52959-002-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001
12	NDC: 52959-002-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2001

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/08/2001

Labeler - H.J. Harkins Company, Inc. (147681894)

Establishment
Name	Address	ID/FEI	Business Operations
H.J. Harkins Company, Inc.		147681894	manufacture(52959-002) , relabel(52959-002) , repack(52959-002)