Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime

acetaminophen and diphenhydramine hydrochloride · Solution · Oral

Over the counter Histamine-1 Receptor Antagonist

Active ingredient

Active ingredients (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg

Purpose

Purpose Pain reliever/Fever reducer Antihistamine/Cough suppressant

Uses

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

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 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
• 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. 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.

Do not use

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

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

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

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

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.

Pregnancy or breast-feeding

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

Keep out of reach of children

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

Directions
• 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 Age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use

Other information

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

Inactive ingredients

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

Questions?

Questions or comments? call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Label text from the FDA structured product label by Haleon US Holdings LLC (revised Apr 26, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime NDC products (1)

NDCStrength & formLabelerType
0031-8770Acetaminophen 650 mg/20mL; Diphenhydramine Hydrochloride 25 mg/20mL
Solution
Haleon US Holdings LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime used for?

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

Who makes Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime?

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime is listed by 1 labeler in the FDA NDC directory, including Haleon US Holdings LLC.