DailyMed - ACETAMINOPHEN tablet

NDC Code(s): 55289-880-01, 55289-880-06, 55289-880-12, 55289-880-20, view more
55289-880-24, 55289-880-30, 55289-880-50, 55289-880-60, 55289-880-97
Packager: PD-Rx Pharmaceuticals, Inc.
This is a repackaged label.
Source NDC Code(s): 16103-376

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated May 29, 2025

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Drug Facts

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Active ingredient (in each tablet)
Acetaminophen 500 mg

Acetaminophen 500 mg
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Purpose
Pain reliever/fever reducer

Pain reliever/fever reducer
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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 ...
- 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
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 4000 mg of acetaminophen in 24 hours - with other drugs containing acetaminophen - 3 or ...
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4000 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
- redness or swelling is present
- new symptoms occur
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 don't notice any signs or symptoms.

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Directions

do not take more than directed (see overdose warning). adult and children 12 years and over - take 2 tablets, every 4 to 6 hours while symptoms last - do not take more than 6 tablets in 24 ...

Other information
store between 20-25 - 0C (68-77 - 0F)
- store between 20-25 0C (68-77 0F)
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Inactive ingredients
povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid
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Questions or comments?
(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)

(866)-562-2756 (Mon - Fri 8 AM to 4 PM EST)
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PRINCIPAL DISPLAY PANEL
Acetaminophen 500mg - TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

Acetaminophen 500mg

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

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INGREDIENTS AND APPEARANCE

Product Information

ACETAMINOPHEN acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55289-880(NDC:16103-376)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	PH044
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55289-880-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
2	NDC:55289-880-12	12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
3	NDC:55289-880-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/09/2019
4	NDC:55289-880-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
5	NDC:55289-880-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
6	NDC:55289-880-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
7	NDC:55289-880-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018
8	NDC:55289-880-97	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2021
9	NDC:55289-880-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/29/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	01/10/2006

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Name	Address	ID/FEI	Business Operations
Establishment
PD-Rx Pharmaceuticals, Inc.		156893695	repack(55289-880)

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Published Date (What is this?)	Version	Files
Jun 2, 2025	15 (current)	download
Mar 24, 2025	14	download
Mar 15, 2024	13	download
Oct 3, 2023	12	download
Sep 25, 2023	11	download
Aug 25, 2022	10	download
Apr 16, 2021	9	download
Mar 29, 2021	8	download
Aug 26, 2020	7	download
Oct 22, 2019	6	download
Sep 10, 2019	5	download
Aug 5, 2019	4	download
Jun 1, 2018	3	download
Jan 16, 2018	2	download

	RxCUI	RxNorm NAME	RxTTY
1	198440	acetaminophen 500 MG Oral Tablet	PSN
2	198440	acetaminophen 500 MG Oral Tablet	SCD
3	198440	APAP 500 MG Oral Tablet	SY

Label: ACETAMINOPHEN tablet

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

adult and children 12 years and over	take 2 tablets, every 4 to 6 hours while symptoms last do not take more than 6 tablets 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

	NDC
1	55289-880-01
2	55289-880-06
3	55289-880-12
4	55289-880-20
5	55289-880-24
6	55289-880-30
7	55289-880-50
8	55289-880-60
9	55289-880-97

Label: ACETAMINOPHEN tablet

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

ACETAMINOPHEN tablet

Number of versions: 14

ACETAMINOPHEN tablet

ACETAMINOPHEN tablet

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ACETAMINOPHEN tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.