Robitussin Direct Sore Throat Pain Tablet, Coated
FDA Label NDC 0031-9301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Direct Sore Throat Pain (NDC 0031-9301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purposes, uses, liver warning:, allergy alert: acetaminophen may cause severe skin reactions. symptoms may include:, do not use, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
  •  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 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
  •  These could be signs of a serious condition.

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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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 18 Caplets (Image 01)

Robitussin Direct Sore Throat Pain 18 Caplets (Image 01)

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