Other
Drug Facts
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.
Distributed by: Pfizer, Madison, NJ 07940 USA
Robitussin Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime Capsule, Liquid Filled
FDA Label NDC 0031-8744
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 Maximum Strength Severe Multi-symptom 7 In 1 Relief Nighttime (NDC 0031-8744). 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 other, otc - purpose, indications & usage, warnings, liver warning, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each liquid-filled capsule) | Purposes |
|---|---|
| Acetaminophen, USP 325 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr, USP 15 mg | Cough suppressant |
| Doxylamine Succinate, USP 6.25 mg | Antihistamine |
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
Warnings
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
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 |
Storage And Handling
Other information
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Inactive Ingredient
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
Otc - Questions
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675
Principal Display Panel - 325 Mg/15 Mg/6.25 Mg Capsule Blister Pack
Robitussin®
Maximum Strength
Severe Multi-Symptom
7 in 1 Relief Nighttime
Each liquid-filled capsule contains:
Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 15 mg
Doxylamine Succinate, USP 6.25 mg
See warnings before use.
Dist. by Pfizer,
Madison, NJ 07940 USA
Made in Canada
TEAR AT NOTCH
PAA102379
P12132
Principal Display Panel - 10 Capsule Blister Pack Carton
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
* Please review the disclaimer below.
