COLD RELIEF NON DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
Western Family Foods Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Active ingredient (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Cough suppressant
Nasal decongestant
Uses
- •
- temporarily relieves these common cold symptoms:
- •
- minor aches and pains
- •
- headache
- •
- sore throat
- •
- nasal congestion
- •
- cough
- •
- sinus congestion and pressure
- •
- helps clear nasal passages
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 12 caplets in 24 hours, 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
- •
- 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.
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- •
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product
do not use more than directed
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- •
- do not take more than directed (see Liver warning)
adults and children 12 years and over
|
- •
- take 2 caplets every 4 hours
- •
- do not take more than 12 caplets in 24 hours
- •
- swallow whole – do not crush, chew or dissolve
|
children under 12 years
|
- •
- do not use this adult product in children under 12 years of age
|
Other information
- •
- store at 20°-25°C (68°-77°F)
Inactive ingredients
acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide
Principal Display Panel
See New Warnings Information
Non-Drowsy
Cold Relief
Aspirin Free
Pain Reliever, Nasal Decongestant, Cough Suppressant
Daytime
Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Gluten Free
Cool Ice®
Instant Cooling Sensation
Caplets
Compare to Tylenol® Cold Head Congestion Daytime active ingredients
Cold Relief Carton Image 2