Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Castor Oil Hypromellose, Unspecified Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;175 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-07-15

Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
sore throat
headache
backache
toothache
premenstrual and menstrual cramps
the common cold
minor pain of arthritis
muscular aches
temporarily reduces fever

Purposes

Pain reliever/Fever reducer

Directions

do not take more than directed
adults and children 12 years of age and over: take 1 caplet every 4 hours, or 2 caplets every 6 hours, while symptoms last
do not take more than 6 caplets in any 24 hours, unless directed by a doctor
do not take for more than 10 days unless directed by a doctor
children under 12 years of age: ask a doctor

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

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

Other Information

store at 25°C (77°F)

Inactive Ingredients

castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Made in China

Lift Here for More Drug Facts

Principal Display Panel

NEW

Robitussin

Sore Throat Pain

Acetaminophen

(Pain Reliever, Fever Reducer)

direct

18 Caplets

Actual size

L-0630-175-44-UPC_ORG - Front Label

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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

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.

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
sore throat
headache
backache
toothache
premenstrual and menstrual cramps
the common cold
minor pain of arthritis
muscular aches
temporarily reduces fever

Purposes

Pain reliever/Fever reducer

Directions

do not take more than directed
adults and children 12 years of age and over: take 1 caplet every 4 hours, or 2 caplets every 6 hours, while symptoms last
do not take more than 6 caplets in any 24 hours, unless directed by a doctor
do not take for more than 10 days unless directed by a doctor
children under 12 years of age: ask a doctor

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

Liver Warning: (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

Other Information (Other information)

store at 25°C (77°F)

Inactive Ingredients (Inactive ingredients)

castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Made in China

Lift Here for More Drug Facts

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Robitussin

Sore Throat Pain

Acetaminophen

(Pain Reliever, Fever Reducer)

direct

18 Caplets

Actual size

L-0630-175-44-UPC_ORG - Front Label

Stop Use and Ask A Doctor If (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.

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

Acetaminophen 500 mg

Allergy Alert: Acetaminophen May Cause Severe Skin Reactions. Symptoms May Include: (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.

Advanced Ingredient Data

[{"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

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