ACETAMINOPHEN by DIRECT RX ACETAMINOPHEN

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
ACETAMINOPHEN- acetaminophen tablet 
DIRECT RX

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ACETAMINOPHEN

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

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
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 of acetaminophen 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

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 the 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

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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: Taking more than the recommended dose (overdose) may cause liver damage. 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 tablets every 4 to 6 hours while symptoms last
do not take more than 10 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor

children 6 years to under 12 years

take 1 tablet every 4 to 6 hours, while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a doctor

children under 6 years ask a doctor

Other information

store at room temperature in a dry place

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Distributed by: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-197(NDC: 51645-703)
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-197-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/28/2021	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	04/28/2021	10/09/2023

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-247(NDC: 57896-104)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-247-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2021	10/09/2023
2	NDC: 72189-247-71	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2021	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	07/23/2021	10/09/2023

Labeler - DIRECT RX (079254320)

Registrant - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	repack(72189-197, 72189-247)

Revised: 10/2023

Document Id: 074b6340-0485-ab05-e063-6294a90adedb

34390-5

Set id: c10b207e-27df-ea5e-e053-2995a90a8db4

Version: 6

Effective Time: 20231009