Acetaminophen by Rising Pharma Holdings, Inc. / Elysium Pharmaceuticals Ltd ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Active Ingredient (in each tablet)                          Purpose
Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

PURPOSE

Uses

To reduce fever and for the temporary relief of minor aches and
pains due to:

• headache 
• muscular aches
• backache
• minor pain from 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 10 tablets in 24 hours, which is the maximum daily amount 
• child takes more than 5 tablets in 24 hours 
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

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 DOCTOR

Ask a doctor before use if you have liver disease.

ASK DOCTOR/PHARMACIST

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 in adults and children.
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.

PREGNANCY 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.
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). Prompt 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
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.
• do not take 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

• SODIUM FREE
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• see end panel for lot number and expiration date.

Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

QUESTIONS

Questions and Comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

Issued: 06/2025

S-065

†This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol® Regular strength.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen

325 mg

100 Film Coated Tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-346
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Off White)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-346-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/09/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Elysium Pharmaceuticals Ltd (863182240)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	analysis(57237-346) , label(57237-346) , manufacture(57237-346) , pack(57237-346)