7decc168-e847-4bbe-910b-26081469406f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/Fever reducer Antihistamine/Cough suppressant
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:
-
•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
Purpose
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
Dosage and 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 |
Description
Drug Facts
Section 42229-5
Drug Facts
Section 44425-7
Other information
-
•each 20 mL contains: sodium 22 mg
-
•store at 20-25°C (68-77°F). Do not refrigerate.
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
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
Section 53413-1
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55106-9
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
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
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
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.
Additional Information
Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.
Distributed by: Haleon, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by Haleon.
©2023 Haleon or licensor.
Pat. Info www.productpats.com
Made in Canada
Principal Display Panel
ADULT
Robitussin
Honey
Nighttime
SEVERE
Cough, Flu +
Sore Throat
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
MAXIMUM STRENGTH
-
✓Controls Cough
-
✓Relieves Runny Nose & Sneezing
-
✓Relieves Fever & Body Aches
Taste the Real Honey
with Vanilla
CF
NIGHTTIME
MAX
For Ages 12+
8 FL OZ (237 mL)
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.
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
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:
-
•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
Dosage and Administration (34068-7)
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 and Precautions (34071-1)
Warnings
Section 42229-5 (42229-5)
Drug Facts
Section 44425-7 (44425-7)
Other information
-
•each 20 mL contains: sodium 22 mg
-
•store at 20-25°C (68-77°F). Do not refrigerate.
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
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
Section 53413-1 (53413-1)
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55106-9 (55106-9)
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Purpose
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 product containing diphenhydramine, even one used on skin
Liver Warning: (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
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.
Additional Information (Additional information)
Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.
Distributed by: Haleon, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by Haleon.
©2023 Haleon or licensor.
Pat. Info www.productpats.com
Made in Canada
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
ADULT
Robitussin
Honey
Nighttime
SEVERE
Cough, Flu +
Sore Throat
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
MAXIMUM STRENGTH
-
✓Controls Cough
-
✓Relieves Runny Nose & Sneezing
-
✓Relieves Fever & Body Aches
Taste the Real Honey
with Vanilla
CF
NIGHTTIME
MAX
For Ages 12+
8 FL OZ (237 mL)
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 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
-
•new symptoms occur
-
•cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (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 (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
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:00.831831 · Updated: 2026-03-14T23:02:51.977564