ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet

ACETAMINOPHEN CAPLETS, 500 MG by

Drug Labeling and Warnings

ACETAMINOPHEN CAPLETS, 500 MG by is a Otc medication manufactured, distributed, or labeled by GRAXCELL PHARMACEUTICAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

ACETAMINOPHEN 500 MG

Purpose

PAIN RELIEVER/FEVER REDUCER

USES

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
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 of acetaminophen in 24 hours
• 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.
• you have ever had an allergic reaction to this productor any of its ingredients

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.

Do not use

without consulting a physician

Ask a physician before use

 if you have a sodium restricted diet due to multiple organ diseases

Stop use and ask a physician

If symptoms of heat cramps continue for more than 24 hours

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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.

Directions

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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

Other information

• Store at room temperature 20°-25°C (68°-77°F).

INACTIVE INGREDIENTS

carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN CAPLETS, 500 MG   EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70795-1200
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70795-1200-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2020
2	NDC: 70795-1200-2	200 in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/16/2020

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)