Drug Facts
e7cf7c5d-5c9a-4201-9e30-1cd616071855
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen, USP 325 mg Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 mg
Purpose
Pain reliever/Fever reducer Cough suppressant Antihistamine
Medication Information
Warnings and Precautions
Warnings
Indications and 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
Purpose
Pain reliever/Fever reducer Cough suppressant Antihistamine
Dosage and 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 |
Description
Acetaminophen, USP 325 mg Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 mg
Section 42229-5
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.
Section 44425-7
Other information
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Section 50565-1
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.
Section 51727-6
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
Section 53413-1
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Purposes
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
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.
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.
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
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
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
Active Ingredients (in Each Liquid Filled Capsule)
Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 15 mg
Doxylamine Succinate, USP 6.25 mg
Structured Label Content
Indications and Usage (34067-9)
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 and Administration (34068-7)
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 and Precautions (34071-1)
Warnings
Section 42229-5 (42229-5)
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.
Section 44425-7 (44425-7)
Other information
- store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Section 50565-1 (50565-1)
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.
Section 51727-6 (51727-6)
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
Section 53413-1 (53413-1)
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
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.
Liver Warning (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 (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.
Principal Display Panel (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
When Using This Product (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 (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
Ask A Doctor Before Use If You Have (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 (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
Active Ingredients (in Each Liquid Filled Capsule) (Active ingredients (in each liquid-filled capsule))
Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 15 mg
Doxylamine Succinate, USP 6.25 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:56.870828 · Updated: 2026-03-14T23:02:45.179164