Label: ROBITUSSIN DIRECT SORE THROAT PAIN- acetaminophen tablet, coated
- NDC Code(s): 0031-9301-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- Purposes
- Uses
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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
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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
- Inactive ingredients
- Questions?call weekdays from 9 AM to 5 PM EST at 1-800-245-1040
- Additional Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROBITUSSIN DIRECT SORE THROAT PAIN
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-9301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-9301-01 18 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/15/2022 Labeler - Haleon US Holdings LLC (079944263)