ACETAMINOPHEN 325MG RS- acetaminophen 325mg tablet
McKesson Corporation dba RX Pak

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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Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with:

headache
backache
muscular aches
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

adult takes more than 4,000 mg in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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

if you are allergic to acetamiophen
with other products containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if user has

liver disease.

Ask a doctor or pharmacist before use if

the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

symptoms do not improve
pain gets worse or lasts for more than 10 days
pain gets worse or lasts more than 5 days in children under 12 years
fever gets worse or lasts for more than 3 days
new symptoms occur
redness or swelling is present
a rare sensitivity reaction occurs
You may report side effects to 1-888-952-0050

If pregnant or breast-feeding

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, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and over: Take 2 tablets every 4 to 6 hours.

Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.

Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use this regular strenght product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

store at room temperature
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

ACETAMINOPHEN 325MG RS (ACETAMINOPHEN 325MG) TABLET

ACETAMINOPHEN 325MG RS
acetaminophen 325mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65084-880(NDC:69168-010)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (Round Circle)	Size	11mm
Flavor		Imprint Code	AZ;010
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65084-880-01	25 in 1 BOX	09/17/2019	07/31/2021
1		30 in 1 BLISTER PACK; 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	04/15/2016	07/31/2021

Labeler - McKesson Corporation dba RX Pak (025183281)

Revised: 2/2021

Document Id: bb023645-b775-7497-e053-2a95a90a3a7e

Set id: 99702813-6071-4d47-9b22-a8d0fe0608c5

Version: 3

Effective Time: 20210210

McKesson Corporation dba RX Pak