FDA Label for Robitussin Direct Sore Throat Pain
View Indications, Usage & Precautions
Robitussin Direct Sore Throat Pain Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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
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
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
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
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Robitussin
Sore Throat Pain
Acetaminophen
(Pain Reliever, Fever Reducer)
direct
18 Caplets
Actual size
L-0630-175-44-UPC_ORG Front Label
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