ACETAMINOPHEN by Cardinal Health, Inc. ACETAMINOPHEN tablet

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 500 mg

PURPOSE

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• for the temporary relief of minor aches and pains due to:
• headache
• the common cold
• backache
• minor pain of arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever

WARNINGS

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.
• 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 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.

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.

DOSAGE & ADMINISTRATION

Directions

• do not take more than directed (see overdose warning)
• ​a dults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor.
• children under 12 years: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature
  

INACTIVE INGREDIENT

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

QUESTIONS

Questions or Comments? call (800) 795-9775

OTHER SAFETY INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

LEADER™

NDC: 70000-0150-3

Extra Strength

Acetaminophen

Tablets, 500 mg

Pain Reliever / Fever Reducer

FOR ADULTS

Aspirin Free

225 TABLETS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0150
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
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (round flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0150-3	225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/17/2016	04/30/2020
2	NDC: 70000-0150-1	1 in 1 CARTON	01/16/2017	05/31/2021
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 70000-0150-2	1 in 1 CARTON	01/16/2017	06/30/2021
3		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/17/2016	06/30/2021

Labeler - Cardinal Health, Inc. (097537435)