Compare To Active Ingredient In Tylenol®
f8237772-7656-49fb-b1de-f8fcb5fa55ee
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient (in each caplet) Purpose Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer
Medication Information
Dosage and Administration
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.
Description
Active Ingredient (in each caplet) Purpose Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Section 50568-5
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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Section 50569-3
Ask a doctor before use if you have liver disease
Section 53413-1
Questions or comments? Call 1-844-474-7464
†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/2258
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 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
Inactive Ingredients
Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
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). Prompt medical
attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label.principal Display Panel
Extra Strength
Acetaminophen
500 mg
NDC 57237-347-05
500 Film Coated Caplets
Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing.
Active Ingredient (in each caplet) Purpose
Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer
Structured Label Content
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Dosage and Administration (34068-7)
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.
Section 50568-5 (50568-5)
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
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Section 50569-3 (50569-3)
Ask a doctor before use if you have liver disease
Section 53413-1 (53413-1)
Questions or comments? Call 1-844-474-7464
†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/2258
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 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 (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
Inactive Ingredients (Inactive ingredients)
Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Keep Out of Reach of Children. (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). Prompt medical
attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
Extra Strength
Acetaminophen
500 mg
NDC 57237-347-05
500 Film Coated Caplets
Do Not Use If Imprinted Safety Seal Under Cap Is Broken Or Missing. (DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.)
Active Ingredient (in each caplet) Purpose
Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:29.110665 · Updated: 2026-03-14T23:13:25.872506