OTCPediatric caution
Fact box
- Therapeutic class
- Opium alkaloids and derivatives
- Action class
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist
- Mechanism
- Uncompetitive NMDA Receptor Antagonists
- Habit forming
- No
- Availability
- Over-the-counter (OTC)
Brand names
AuvelityBabee CofBromfed DMBuckley's Cough SuppressantCepacol Sore Throat Plus CoughCepastat Sore Throat & CoughChloraseptic Sore Throat + CoughCreomulsionDayQuil CoughDelsymElixsure CoughMielim Y MasNuedextaRobafen CoughScot-Tussin DM Cough ChasersScot-tussin Diabetic CFZicam Cough
Available as
6 MG/ML · Oral Solution0.8 MG/ML · Oral Solution1 MG/ML · Oral Solution0.667 MG/ML · Oral Solution7.5 MG20 MG · Oral Capsule21.7 MG/ML · Oral Solution33.3 MG/ML · Oral Solution325 MG · Oral Capsule2 MG/ML · Oral Solution6 MG32 MG/ML · Oral Suspension325 MG · Oral Tablet500 MG · Oral Tablet0.2 MG/ML · Oral Solution10 MG · Oral Capsule250 MG · Oral Capsule15 MG · Oral Capsule3 MG/ML · Oral Solution4 MG/ML · Oral Solution65 MG/ML · Oral Solution15 MG · Oral Tablet5 MG/ML · Oral Solution60 MG · Extended Release Oral Tablet
FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.
Uses
Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever
How to use / dosing
Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use
Safety advice
Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.
PregnancyConsult your doctor
…If pregnant or breast-feeding, ask a health professional before use.…
BreastfeedingConsult your doctor
…If pregnant or breast-feeding, ask a health professional before use.…
AlcoholConsult your doctor
…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.…
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverConsult your doctor
…Warnings Liver warning: This product contains acetaminophen.…
Warnings & precautions
Warnings Liver warning: This product contains acetaminophen. 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 inclide: 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 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion 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 a rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Pediatric use
Pediatric caution
OTC cough-and-cold products are not recommended for children <4 years (FDA) / <6 years (AAP) due to lack of efficacy and risk of serious adverse effects.
Source: FDA OTC cough/cold advisory; AAP guidance.
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
- 12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]
- SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]
- NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]
- PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION [ATLANTIC BIOLOGICALS CORP.]
- AGRIFEN (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [OPMX LLC]
359 marketed products on record (RxNorm)
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.