Right Remedies

Right Remedies
SPL v2
SPL
SPL Set ID dcce28d9-8528-489e-b995-1d98e9d0e6ad
Route
ORAL
Published
Effective Date 2023-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Water Sodium Starch Glycolate Type A Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-20

Description

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500mg

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 fever.

Section 42229-5

*compare to the active ingredient of Extra Strength Tylenol®

TAMPER EVIDENT. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

Distributed by: Strive Pharmaceuticals inc. East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Caplets.

REV.00- 102022

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 have ever had an allergic reaction to this product or any of its ingredients.

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 • 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.

Packaging

Directions

Do not take more than directed. See overdose warning

 adult & children

12 years of age

and over

 • take 2 caplets every 6 hours while symptoms last

 • do not take more than 6 caplets in 24 hours unless directed by a doctor

 • do not take more than 10 days, unless directed by a doctor

 children under

12 years of age

 • ask a doctor

Other Information

each caplet contains: sodium 1 mg (very low sodium)

• store at room temperature between 20 - 25ºC (68-77ºF).

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone k30, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide

Questions Or Comments?

1-888-577-8033  Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Caplet)

Acetaminophen 500mg


Structured Label Content

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 fever.

Section 42229-5 (42229-5)

*compare to the active ingredient of Extra Strength Tylenol®

TAMPER EVIDENT. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

Distributed by: Strive Pharmaceuticals inc. East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Caplets.

REV.00- 102022

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Pain reliever/fever reducer

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 have ever had an allergic reaction to this product or any of its ingredients.

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 • 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.

Packaging

Directions

Do not take more than directed. See overdose warning

 adult & children

12 years of age

and over

 • take 2 caplets every 6 hours while symptoms last

 • do not take more than 6 caplets in 24 hours unless directed by a doctor

 • do not take more than 10 days, unless directed by a doctor

 children under

12 years of age

 • ask a doctor

Other Information (Other information)

each caplet contains: sodium 1 mg (very low sodium)

• store at room temperature between 20 - 25ºC (68-77ºF).

• avoid excessive heat, cold and humidity.

• close cap tightly after use.

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone k30, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-577-8033  Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))

Acetaminophen 500mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)