Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime ACETAMINOPHEN DIPHENHYDRAMINE HCL HALEON US HOLDINGS LLC FDA Approved Uses temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies: cough due to minor throat and bronchial irritation headache sore throat minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves your cough to help you rest temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid artificial flavor edetate disodium FD&C red no. 40 glycerin menthol polyethylene glycol propyl gallate propylene glycol purified water sodium benzoate sodium citrate sorbitol solution sucralose
Strengths
20 ml 650 mg 25 mg
Quantities
237 ml 118 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Occurring With A Cold Or Flu Hay Fever Or Other Respiratory Allergies Cough Due To Minor Throat And Bronchial Irritation Headache Sore Throat Minor Aches And Pains Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat Temporarily Relieves Your Cough To Help You Rest Temporarily Reduces Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D TC2D6JAD40
Packaging

PRINCIPAL DISPLAY PANEL ADULT NEW FORMULA HALEON Robitussin MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM Cough Cold + Flu Nighttime ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) Relieves Cough to Help You Rest ✓Cough, Sore Throat ✓Head & Body Aches, Fever ✓Runny Nose, Sneezing FAST, POWERFUL multi-symptom relief CF NIGHTTIME MAX For Ages 12 & Over 4 FL OZ (237 mL) 207723 Front Carton Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)

Package Descriptions
  • PRINCIPAL DISPLAY PANEL ADULT NEW FORMULA HALEON Robitussin MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM Cough Cold + Flu Nighttime ACETAMINOPHEN (Pain Reliever/Fever Reducer) DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant) Relieves Cough to Help You Rest ✓Cough, Sore Throat ✓Head & Body Aches, Fever ✓Runny Nose, Sneezing FAST, POWERFUL multi-symptom relief CF NIGHTTIME MAX For Ages 12 & Over 4 FL OZ (237 mL) 207723 Front Carton Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 drug containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease trouble urinating due to an enlarged prostate gland glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other pain reliever/fever reducer taking sedatives or tranquilizers When using this product 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.
Purpose

Purposes Pain reliever/Fever reducer Antihistamine/Cough suppressant

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 drug containing diphenhydramine, even one used on skin

When Using

When using this product 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 & 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.

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.

Storage & Handling

Other information each 20 mL contains: sodium 12 mg store at 20-25°C (68-77°F)

Questions

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


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