DailyMed - ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

NDC Code(s): 51660-333-01, 51660-333-24, 51660-333-50
Packager: Ohm Laboratories Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 13, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient (in each caplet)
Acetaminophen USP, 650 mg

Acetaminophen USP, 650 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: minor pain of arthritis - muscular aches - backache - premenstrual and menstrual cramps - the common cold - headache - toothache - temporarily ...
- temporarily relieves minor aches and pains due to:
  - minor pain of arthritis
  - muscular aches
  - backache
  - premenstrual and menstrual cramps
  - the common cold
  - headache
  - toothache
- temporarily reduces fever
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Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 caplets in 24 hours, which is the maximum daily amount - with other drugs containing ...
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- 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 haveliver disease.

Ask a doctor or pharmacist before use if you aretaking 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.

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Directions

do not take more than directed (see - overdose warning) adults - take 2 caplets every 8 hours with water - swallow whole; do not crush, chew, split or dissolve - do not take ...

Other information
store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date - TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM ...
- store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
- see end panel for batch number and expiration date
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
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Inactive ingredients
crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide
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Questions?
call - 1-800-406-7984

call 1-800-406-7984
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SPL UNCLASSIFIED SECTION
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
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PRINCIPAL DISPLAY PANEL - 650 mg CAPLET Bottle Carton
NDC 51660-333-50 - †Compare To the active ingredient of Tylenol - ®Arthritis Pain - Ohm - ® Last up to 8 Hours - Use only as directed. Arthritis Pain ...
NDC 51660-333-50

†Compare To the active ingredient of Tylenol ®Arthritis Pain

Ohm ®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

50 CAPLETS* (*Capsule-Shaped Tablets)

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Package/Label Principal Display Panel
NDC 51660-333-01 - †Compare To the active ingredient of Tylenol - ®Arthritis Pain - Ohm - ® Last up to 8 Hours - Use only as directed. Arthritis Pain ...
NDC 51660-333-01

†Compare To the active ingredient of Tylenol ®Arthritis Pain

Ohm ®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

100 CAPLETS* (*Capsule-Shaped Tablets)

Close
Principal Display Panel
NDC 51660-333-24 - †Compare To the active ingredient of Tylenol - ®Arthritis Pain - Ohm - ® Last up to 8 Hours - Use only as directed. Arthritis Pain ...
NDC 51660-333-24

†Compare To the active ingredient of Tylenol ®Arthritis Pain

Ohm ®

Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer
- For the Temporary Relief of Minor Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

24 CAPLETS* (*Capsule-Shaped Tablets)

Close

INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	manufacture(51660-333)

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Published Date (What is this?)	Version	Files
Jan 14, 2025	10 (current)	download
Nov 5, 2021	9	download
Aug 3, 2020	8	download
Nov 12, 2019	7	download
Jan 5, 2018	6	download
Dec 6, 2017	5	download
Jan 25, 2016	4	download
Jun 2, 2014	3	download
May 31, 2012	2	download
May 23, 2012	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN
2	1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD
3	1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY
4	1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY

Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Liver warning

Allergy alert

Do not use

Stop use and ask a doctor if

Overdose warning

Find additional resources

Safety

Related Resources

More Info on this Drug

adults	take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

	NDC
1	51660-333-01
2	51660-333-24
3	51660-333-50

Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Liver warning

Allergy alert

Do not use

Stop use and ask a doctor if

Overdose warning

Find additional resources

Safety

Related Resources

More Info on this Drug

ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

Number of versions: 10

ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

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ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

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