FDA Label for Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- LIVER WARNING
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 237 ML BOTTLE CARTON
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - Purpose
| Active ingredients (in each 20 ml) | Purposes |
|---|---|
| Acetaminophen, USP 650 mg | Pain reliever/Fever reducer |
| Diphenhydramine HCl, USP 25 mg | Antihistamine/Cough suppressant |
Indications & 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
Warnings
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
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 product containing diphenhydramine, even one used on skin
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
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.
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 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 |
Storage And Handling
Other information
- each 20 ml contains: sodium 22 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
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
Otc - Questions
Questions or comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Principal Display Panel - 118 Ml Bottle Label
ADULT
Robitussin®
Honey
MAXIMUM STRENGTH
Nighttime
SEVERE
Cough, Flu +
Sore Throat
CF
NIGHTTIME
MAX
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
ADULT
NEW!
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
TRUE
SOURCE
CERTIFIED
HONEY✔™
CF
NIGHTTIME
MAX
For Ages 12+
4 FL OZ (118 ml)
Principal Display Panel - 237 Ml Bottle Label
ADULT
Robitussin®
Honey
MAXIMUM STRENGTH
Nighttime
SEVERE
Cough, Flu +
Sore Throat
CF
NIGHTTIME
MAX
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
8 FL OZ (237 ml)
Principal Display Panel - 237 Ml Bottle Carton
ADULT
NEW!
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
TRUE
SOURCE
CERTIFIED
HONEY✔™
CF
NIGHTTIME
MAX
For Ages 12+
8 FL OZ (237 ml)
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