COLD RELIEF- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl
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.
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Western Family Cold Relief Drug Facts
Active ingredient (in each caplet) (NIGHT)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredient (in each caplet) (DAY)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses (NIGHT)
- •
- temporarily relieves these common cold symptoms:
- •
- headache
- •
- nasal congestion
- •
- minor aches and pains
- •
- cough
- •
- sore throat
- •
- sinus congestion and pressure
- •
- sneezing and runny nose
- •
- helps clear nasal passages
- •
- relieves cough to help you sleep
Uses (DAY)
- •
- temporarily relieves these common cold symptoms:
- •
- headache
- •
- nasal congestion
- •
- minor aches and pains
- •
- cough
- •
- sore throat
- •
- sinus congestion and pressure
- •
- helps clear nasal passages
Warnings (NIGHT)
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.
- •
- to make a child sleepy
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)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- glaucoma
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not use more than directed
- •
- excitability may occur, especially in children
- •
- marked drowsiness may occur
- •
- alcohol, sedatives and tranquilizers may increase drowsiness
- •
- avoid alcoholic drinks
- •
- be careful when driving a motor vehicle or operating machinery
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.
Warnings (DAY)
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)
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.
Directions (NIGHT)
- •
- do not take more than directed (see Liver warning)
- •
- do not take the Day and Night caplets at the same time
- •
- do not take more than a total of 12 caplets in 24 hours
|
adults and children 12 years and over |
|
|
children under 12 years |
do not use this adult product in children under 12 years of age |
Directions (DAY)
- •
- do not take more than directed (see Liver warning)
- •
- do not take the Day and Night caplets at the same time
- •
- do not take more than a total of 12 caplets in 24 hours
|
adults and children 12 years and over |
|
|
children under 12 years |
do not use this adult product in children under 12 years of age |
Inactive ingredients (NIGHT)
acesulfame potassium, blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (DAY)
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
COOL ICE® CAPLETS
Instant Cooling Sensation
Cold Relief
ASPIRIN FREE
Pain Reliever, Nasal Decongestant, Cough Suppressant, †Antihistamine
DAYTIME
Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Non-Drowsy
NIGHTTIME
Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Runny Nose – Chlorpheniramine Maleate
†Antihistamine in Nighttime Only
COMPARE TO TYLENOL® COLD HEAD CONGESTION DAY AND NIGHT active ingredients
Cold Relief Carton Image 2
| COLD RELIEF
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit |
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| Labeler - Western Family Foods Inc (192166072) |