Purpose
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 20 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
INDICATIONS & USAGE SECTION
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 SECTION
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
SPL UNCLASSIFIED SECTION
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- •skin reddening
- •blisters
- •rash
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
Directions
| adults and children 12 years and over | 20 mL every 4 hours |
| children under 12 years | do not use |
- •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
STORAGE AND HANDLING SECTION
Other information
- •each 20 mL contains: sodium 22 mg
- •store at 20-25°C (68-77°F). Do not refrigerate.
INACTIVE INGREDIENT SECTION
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 SECTION
Questions or comments?
call weekdays from 8 AM to 6 PM EST at 1-800-245-1040
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