Extra Strength Acetaminophen Liquid Capsules, 500 mg Drug Facts

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen capsule, liquid filled
AMERISOURCEBERGEN DRUG CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Extra Strength Acetaminophen Liquid Capsules, 500 mg

Drug Facts

Active ingredient (in each softgel)

Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

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 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.

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 capsules every 6 hours while symptoms last do not take more than 6 capsules 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°C to 25°C (68°F to 77°F)
do not use if printed foil under cap is broken or missing

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

Questions or comments?

Call toll free 1-800-706-5575

*This product is not manufactured or distributed by McNeil Healthcare LLC, Inc., owner of the registered trademark TYLENOL® Extra Strength.

Principal Display Panel

OTC Medicine

Acetaminophen, USP 500 mg

Pain reliever/fever reducer

80 liquid capsules/500 mg each

NDC: 46122-388-41

ACETAMINOPHEN
acetaminophen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-388
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K12 (UNII: 333AG72FWJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
1,4-SORBITAN (UNII: AV0YTZ4E6J)

Product Characteristics
Color	RED (RED-B2C)	Score	no score
Shape	OVAL (Oblong)	Size	24mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 46122-388-41	1 in 1 CARTON	02/01/2017	08/31/2019
1		80 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	02/01/2017	08/31/2019

Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)

Registrant - Apotex Inc. (209429182)

Revised: 3/2020

Document Id: 75b96d22-ef5f-742f-826c-940861d48580

Set id: 746fefe3-04c6-9ba3-2d17-7ef2399815bb

Version: 2

Effective Time: 20200306

AMERISOURCEBERGEN DRUG CORPORATION