GOOD SENSE COLD HEAD CONGESTION SEVERE
-
acetaminophen,
dextromethorphan hydrobromide,
guaifenesin and
phenylephrine hydrochloride tablet, coated
L Perrigo Company
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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Active ingredient (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- headache
- nasal congestion
- impulse to cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis 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
- do not take more than directed (see Liver warning)
| adults and children 12 years and over |
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| children under 12 years |
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Inactive ingredients
acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
Principal Display Panel
Pain Relief
See New Warnings Information
Cold Head Congestion
Daytime Non-Drowsy
Severe
Instant Cooling Sensation
Cool Ice®
Headaches/Sore Throat/Nasal Congestion
Coughing/Chest Congestion
Pain Reliever•Fever Reducer/Acetaminophen
Nasal Decongestant/Phenylephrine HCl
Cough Suppressant/Dextromethorphan HBr
Expectorant/Guaifenesin
Compare to active ingredients of Tylenol® Cold Head Congestion Severe
Cold Head Congestion Carton Image 1
Cold Head Congestion Carton Image 2
| GOOD SENSE COLD HEAD CONGESTION
SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 02/23/2008 | |
| Labeler - L Perrigo Company (006013346) |
Revised: 12/2009 L Perrigo Company