ROBITUSSIN DIRECT SORE THROAT PAIN- acetaminophen tablet, coated

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 500 mg
Purposes

Pain reliever/Fever reducer
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
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.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 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
- redness or swelling is present
- new symptoms occur
- 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. 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 for children even if you do not notice any signs or symptoms.
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
Other information
- store at 25°C (77°F)
Inactive ingredients

castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions?call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
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

Trademarks owned or licensed by GSK ©2022 GSK or licensor

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

ROBITUSSIN DIRECT SORE THROAT PAIN
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-9301
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0031-9301-01	18 in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	07/15/2022

Labeler - Haleon US Holdings LLC (079944263)

ROBITUSSIN DIRECT SORE THROAT PAIN- acetaminophen tablet, coated

Robitussin Direct Sore Throat Pain by

Drug Labeling and Warnings

Drug Details [pdf]

Liver warning:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. 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 for children even if you do not notice any signs or symptoms.