ACETAMINOPHEN tablet, coated

acetaminophen by

Drug Labeling and Warnings

acetaminophen by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 325 mg

PURPOSE

Pain reliever/fever reducer

INDICATIONS & USAGE

temporarily relieves of minor aches and pains due to:

■ headache

■ muscular aches

■ minor arthritis pain

■ backache

■ the common cold

■ toothache

■ 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 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.

■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

ASK DOCTOR

Ask a doctor before use if you have

■ liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

STOP USE

Stop using and ask a doctor if

■ pain gets worse and lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

■ do not use more than directed (see overdose warning)

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, 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

INACTIVE INGREDIENT

corn starch, hypromellose, polyethylene glycol, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

OVERDOSAGE

Overdose Warning:

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.

STORAGE AND HANDLING

■ store at room temperature 59º-86ºF (15º-30ºC)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

HOW SUPPLIED

2 in 1 packet; 1 packet in 1 pouch.

NDC:

51662-1665-2

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1665(NDC:68599-4679)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ;234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1665-2	1 in 1 POUCH	04/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/01/2021

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	repack(51662-1665)