Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE HALEON US HOLDINGS LLC FDA Approved Uses temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies: headache sore throat cough minor aches and pains runny nose sneezing itchy, watery eyes itching of the nose or throat 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 liquid-filled capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine Succinate USP 6.25 mg
Inactive Ingredients
Inactive ingredients D&C yellow no. 10 FD&C blue no. 1 gelatin glycerin mineral oil pharmaceutical ink polyethylene glycol povidone propylene glycol purified water sorbitol sorbitan solution
Strengths
325 mg 15 mg 6.25 mg
Quantities
7 count
Treats Conditions
Uses Temporarily Relieves These Symptoms Occurring With A Cold Or Flu Hay Fever Or Other Upper Respiratory Allergies Headache Sore Throat Cough Minor Aches And Pains Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: green Imprint: R

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

PRINCIPAL DISPLAY PANEL ADULT Robitussin ® MAXIMUM STRENGTH SEVERE Multi-Symptom 7 in 1 Relief ACETAMINOPHEN (Pain Reliever/Fever Reducer) DEXTROMETHORPHAN HBr (Cough Suppressant) DOXYLAMINE SUCCINATE (Antihistamine) CF NIGHTTIME MAX Cough, Sore Throat Body Aches, Fever Runny Nose, Sneezing Itchy Throat For Ages 12 & Over 10 LIQUID-FILLED CAPSULES Robitussin MS S Multi Sym 10 Caps Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL ADULT Robitussin ® MAXIMUM STRENGTH SEVERE Multi-Symptom 7 in 1 Relief ACETAMINOPHEN (Pain Reliever/Fever Reducer) DEXTROMETHORPHAN HBr (Cough Suppressant) DOXYLAMINE SUCCINATE (Antihistamine) CF NIGHTTIME MAX Cough, Sore Throat Body Aches, Fever Runny Nose, Sneezing Itchy Throat For Ages 12 & Over 10 LIQUID-FILLED CAPSULES Robitussin MS S Multi Sym 10 Caps Blister Pack Carton

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than 8 capsules in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 capsules every 6 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 8 capsules 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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema 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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur 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 Cough suppressant Antihistamine

Do Not Use

Do not use to sedate a child or to make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. new symptoms occur

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 store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Questions

Questions or comments? Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675


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