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Purpose


SPL UNCLASSIFIED SECTION

Drug Facts


OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg


Purpose

Pain reliever/Fever reducer

Antihistamine/Cough suppressant


INDICATIONS & USAGE SECTION

Uses

  • •temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:•cough due to minor throat and bronchial irritation•minor aches and pains•sore throat pain•headache•runny nose, sneezing, itchy watery eyes•itching of the nose and throat
  • •temporarily relieves your cough to help you sleep
  • •temporarily reduces fever

WARNINGS SECTION

Warnings


Liver warning:

This product contains acetaminophen.

Severe liver damage may occur if you take

  • •more than 6 doses in any 24-hour period, which is the maximum daily amount
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

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

If a skin reaction occurs, stop use and seek medical help right away.

  • •skin reddening
  • •blisters
  • •rash

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

  • •to sedate a child or to make a child sleepy
  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • •liver disease
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis
  • •if you have glaucoma or difficulty in urination due to enlargement of prostate gland

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers
  • •taking the blood thinning drug warfarin
  • •taking any other pain reliever/fever reducer

When using this product

  • •do not use more than directed
  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children

Stop use and ask a doctor if

  • •pain or cough gets worse or lasts more than 7 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur
  • •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.


DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years and over20 mL every 4 hours
children under 12 yearsdo not use
  • •do not take more than 6 doses in any 24-hour period
  • •do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL = milliliter
  • •this adult product is not intended for use in children under 12 years of age

STORAGE AND HANDLING SECTION

Other information

  • •each 20 mL contains: sodium 22 mg
  • •store at 20-25°C (68-77°F). Do not refrigerate.

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum


OTC - QUESTIONS SECTION

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040


Additional information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Distributed by: Haleon, Warren, NJ 07059

For most recent product information, visit www.robitussin.com

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

Pat. Info www.productpats.com

Made in Canada