Cold and Sinus
Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride · Liquid · Oral
Active ingredient
Drug Facts Active ingredients (in each 20 mL) Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg
Purpose
Purpose Pain reliever/Fever reducer Expectorant Nasal decongestant
Uses
Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Warnings Liver warning This product contains acetamnophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. 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
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. for children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning product warfarin.
When using this product
When using this product do not use more that directed
Stop use and ask a doctor
stop use and ask a doctor if nervousness, dizziness or sleeplessness occur redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache. These could be signs of a serious condition.
Pregnancy or breast-feeding
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children
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.
Directions
Directions take only as recommended (see Overdose warning) use dosage cup mL = milliliter do not take more han 6 doses in any 24-hour period Age Dose Adults & children 20 mL every 4 hours 12 years and older Children under 12 Do not use years of age
Inactive ingredients
Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum
Questions?
Questions? Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944
Label text from the FDA structured product label by DeMoulas Market Basket (revised Dec 29, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Guaifenesin in 1 product
- Phenylephrine Hydrochloride in 1 product
Cold and Sinus NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 53942-515 | Acetaminophen 650 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine Hydrochloride 10 mg/20mL Liquid | DeMoulas Market Basket | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Cold and Sinus used for?
Uses temporarily relieves these common cold and flu symptoms: nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Who makes Cold and Sinus?
Cold and Sinus is listed by 1 labeler in the FDA NDC directory, including DeMoulas Market Basket.