ACETAMINOPHEN 500MG tablet

Acetaminophen 500mg by

Drug Labeling and Warnings

Acetaminophen 500mg by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen 500mg

INACTIVE INGREDIENT

colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycolate

DOSAGE & ADMINISTRATION

• take with a full glass of water
• do not take more than directed

• adults and children 12 years of age 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 of age: ask a doctor

INDICATIONS & USAGE

*temporarily relieves minor aches and pains due to:

• the common cold
• headache
• backache
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps

*temporarily reduces fever

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4000mg 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 non prescription). 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 a doctor before use if you have

• liver disease

Ask a doctor or a 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 comdition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Overdose Warning: 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.

PURPOSE

Pain reliever / Fever reducer

OTHER SAFETY INFORMATION

• store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 500MG 
acetaminophen 500mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-117
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-117-41	4 in 1 PACKAGE; Type 0: Not a Combination Product	12/20/2018
2	NDC: 70692-117-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/20/2018

Labeler - Strive Pharmaceuticals Inc (080028013)