ACETAMINOPHEN by HF Acquisition Co LLC, DBA HealthFirst ACETAMINOPHEN tablet

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 500 mg

PURPOSE

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses
For the temporary relief of minor aches and pains associated with

headache
muscular aches
minor arthritis pain
common cold
toothache
menstrual cramps

For the reduction of fever.

WARNINGS

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

STOP USE

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 taking the blood thinning drug warfarin

Stop using 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

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.

DOSAGE & ADMINISTRATION

Directions

do not use more than directed

Adults and children: (12 years and older)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 to children under 12 years of age

OTHER SAFETY INFORMATION

Other information

store at room temperature 59º-86ºF (15º-30ºC)
tamper-evident sealed packets
do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain

QUESTIONS

Questions or comments?1-800-777-4908

ASK DOCTOR

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

Stop using 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.

HOW SUPPLIED

51662-1666-2 2Pack

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1666(NDC:68599-4681)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	0.5 g  in 1 g

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1666-2	2 in 1 PACKET	01/30/2020
1		0.5 g 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 Drug	M013	01/30/2020

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(51662-1666)